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`a short effective transmission range, e.g., no more than between about 20 and 40 cm, such
`
`as about 30 cm. Such a short range reduces the likelihood of accidental communication
`
`with a data carrier other than the intended data carrier.
`
`For some applications, a portion of the patient information stored in the data
`
`5
`
`carrier is also printed in human- and/or machine-readable form on the data carrier. For
`
`example, a name 172 and identification code 174 of the patient, and/or a barcode 176 may
`
`be printed on the data carrier.
`
`Data carrier 24 comprises circuitry 178, which comprises memory and logic. For
`
`some applications, data carrier 24 is passive, in which case it is configured to receive
`
`10
`
`energy from communication element 240. For other applications, data carrier 24
`
`comprises a power source (not shown). For some applications in which the data carrier
`
`comprises a power source, the data carrier comprises a communication element for
`
`communicating and/or energizing another electronic apparatus.
`
`Alternatively or
`
`additionally, the data carrier comprises a communication element configured for wireless
`
`15
`
`cbmmunication.
`
`For some applications, data carrier 24 further comprises a user output 180 for
`
`outputting information to the patient or healthcare workers. For example, output 180 may
`
`comprise a display screen, light, and/or sound generator, which circuitry 178 drives to
`
`communicate information, such as when communications have been established with
`
`20
`
`other elements of system 10, e.g., data carrier 120, administration system 26, imaging
`
`system 28, and/or patient management system 160. For some applications, circuitry 178
`
`is configured to additionally function as an alarm clock; for example, the circuitry may
`
`drive display 180 to alert the patient prior to a scheduled administration or imaging
`
`procedure.
`
`25
`
`Typically, for safety purposes, upon completion of all the imaging procedures
`
`associated with a given patient-specific data carrier 24, system 10 permanently disables
`
`the data carrier, in order to ensure that the data carrier is not accidentally reused for
`
`another patient.
`
`The patient management system
`
`30
`
`Reference is made to Fig. 4, which is a schematic illustration of patient
`
`management system 160, in accordance with an embodiment of the present invention.
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`Patient management system 160 manages patient-related administrative and medical
`
`information, and typically comprises at least one workstation 200 in communication with
`
`one or more servers 202. Typically, workstation 200 and servers 202 comprise standard
`
`personal computers and/or computer servers with appropriate memory, communication
`
`5
`
`interfaces and software for carrying out the functions prescribed by relevant embodiments
`
`of the present invention. This software may be downloaded to the workstation and
`
`servers in electronic form over a network, for example, or it may alternatively be supplied
`
`on tangible media, such as CD-ROM.
`
`System 160 performs the following functions:
`
`10
`
`•
`
`receives and registers new patients into system 10, typically into
`
`management and control component 150 thereof;
`
`• assigns patient identification codes;
`
`• assigns, issues, and transfers information to patient-specific data carriers
`
`24;
`
`15
`
`•
`
`receives and tracks patient prescriptions for radiopharmaceuticals, and
`
`communicates the prescriptions to other elements of system 10, such as
`
`dispensing system 20, administration system 26, and/or management and
`
`control component 150; and/or
`
`• suggests and assigns imaging protocols based on the patient's imaging
`
`20
`
`needs and patient-specific information.
`
`During reception of a new patient 204, healthcare worker 206 manually enters
`
`patient information into workstation 200. Alternatively or additionally, all or a portion of
`
`the patient information is provided electronically by another healthcare system or
`
`electronic information source. System 160 typically verifies the healthcare worker's
`
`25
`
`identity and access privileges by interrogating a computer-commuticatable identity tag
`
`208 held by the worker, and/or by checking the validity of a password entered into
`
`workstation 200 by the healthcare worker.
`
`The patient information provided to system 160 typically includes:
`
`•
`
`the patient's general details, such as name, age, gender, address, telephone number,
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`30
`
`profession, attending and/or treating physician, health insurance plan, and next of
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`•
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`the patient's medical profile, such as medical condition, medical history, family
`
`medical history, BMI, weight, allergies, sensitivity to one or more chemical
`
`compounds, metabolic rate, and other physiological conditions;
`
`5
`
`• medications prescribed to the patient;
`
`•
`
`•
`
`the patient's imaging history; and/or
`
`information regarding the desired imaging, including reason for imaging, type of
`
`imaging, body structure or organ to be imaged, and known or suspected pathology.
`
`In an embodiment of the present invention, upon entry of such patient information
`
`10
`
`into patient management system 160, the system automatically suggests one or more
`
`imaging protocols that may be appropriate for the patient's imaging needs and medical
`
`condition. When making such suggestion, the system takes into consideration, in addition
`
`to the information regarding the desired imaging, such factors as the patient's general
`
`details, medical profile, imaging history, and guidelines for medication interactions. The
`
`15
`
`system typically selects the suggested protocol(s) from a database of preconfigured
`
`protocols, which is described hereinbelow with reference to Figs. 6A-E. Healthcare
`
`worker 206 selects one of the suggested protocols, or selects another non-suggested
`
`protocol directly from the protocol database.
`
`For some applications, the system suggests one or more customizations of the
`
`20
`
`selected protocol, as described hereinbelow with reference to Figs. 6A-E, which the
`
`healthcare worker may accept, decline, or modify, in whole or in part. These suggested
`
`customizations are typically based on (a) physiological parameters of the patient, such as
`
`age, weight, BMI, metabolic rate, and/or hemodynamic state, and/or kinetic parameters of
`
`the radiopharmaceutical agent as determined during previous imaging procedures
`
`25
`
`performed on the patient, and/or (b) a medical profile group to which the patient is
`
`assigned, such as high, normal, or low BMI, or high BMI - diabetic, or high BMI - normal
`
`metabolic rate. (For some applications, such profile groups are stored in a database of
`
`management and control component 150.) Alternatively or additionally, the healthcare
`
`worker may customize the protocol manually.
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`30
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`Upon selection and customization of the protocol, patient management system 160
`
`schedules, typically automatically:
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`• a specific imaging system 28 capable of performing the selected imaging
`
`procedure;
`
`• a date and time for performing the imaging. procedure; and.
`
`• a date(s) and time(s) for administration of labeled radiopharmaceutical
`
`5
`
`agent(s).
`
`Patient management system 160
`
`transmits
`
`the entered and generated
`
`patient-specific
`
`information,
`
`including
`
`the
`
`selected protocol,
`
`to
`
`the patient's
`
`patient-specific data carrier 24. The transmitted patient-specific information typically
`
`includes:
`
`10
`
`•
`
`the patient's identification code and name;
`
`• an identifier of the selected imaging protocol(s), such as a name and/or an
`
`identification code
`
`thereof,
`
`and/or
`
`additional
`
`imaging protocol
`
`information, such as described hereinbelow with reference to Figs. 6A-E;
`
`• an identifier of the selected administration protocol(s), such as a name
`
`15
`
`and/or an identification code thereof;
`
`•
`
`the scheduled imaging system 28;
`
`•
`
`•
`
`the scheduled imaging date and time;
`
`the scheduled administration date(s) and time(s);
`
`•
`
`the patient's personal details;
`
`20
`
`•
`
`•
`
`the patient's medical profile; and/or
`
`the patient's imaging history.
`
`The patient management system
`
`transmits an order
`
`for one or more
`
`patient-specific doses of the appropriate
`
`labeled radiopharmaceutical agent(s)
`
`to
`
`dispensing system 20, such as via management and control component 150. Typically,
`
`25
`
`the patient management system additionally transmits at least a portion of the entered and
`
`generated patient-specific information to one or more of: (a) management and control
`
`component 150, (b) dose calculation system 152, (c) administration system 26, and/or (d)
`
`imaging system 28. Typically, a different subset of the information is transmitted to each
`
`of these entities.
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`As described hereinabove with reference to Fig. 3, for some applications, a portion
`
`of the patient information stored in data carrier 24 is also printed in human- and/or
`
`machine-readable form on the data carrier. For example, a name 172 and identification
`
`code 174 of the patient, and/or a barcode 176 may be printed on the data carrier. For such
`
`5
`
`applications, system 160 comprises a printer 210, which is configured to print the
`
`information directly on data carrier 24, or to print the information on an adhesive label,
`
`which healthcare worker 206 attaches to data carrier 24. For some applications, printer
`
`210 comprises communication element 240, and the printer is configured to both print the
`
`information on the data carrier and transmit the information to the data carrier, typically
`
`10
`
`generally at the same time.
`
`In an embodiment of the present invention, system 10 comprises at least one web
`
`server, which is configured to accept orders for an imaging procedure over an intranet or
`
`the Internet, placed by a physician or other healthcare worker. Such orders can typically
`
`be modified up until a deadline, such as midnight before the day of the scheduled imaging
`
`15
`
`procedure.
`
`The management and control component
`
`Reference is again made to Fig. 1.
`
`In an embodiment of the present invention,
`
`system 10 comprises management and control component 150, which coordinates a
`
`portion of the interaction and communication among the elements of system 10. The
`
`20
`
`remainder of the interaction and communication occurs directly between the elements of
`
`the system, and/or via other elements of the system. For some applications, component
`
`150 issues a password and/or computer-communicatable identity tags 208 to healthcare
`
`workers 206 authorized to interact with one or more elements of system 10. For example,
`
`tag 208 may comprise an RFID tag, smart card, disk-on-key (e.g., a USB key), minidisk,
`
`25
`
`or other electronic memory, or a machine-readable code, e.g., a barcode. As appropriate,
`
`healthcare workers 206 may be assigned various permission levels, such as permission to
`
`view or modify particular system and/or patient data.
`
`Typically, management and control component 150 comprises one or more
`
`standard personal computers or servers with appropriate memory, communication
`
`30
`
`interfaces and software for carrying out the :functions prescribed by relevant embodiments
`
`of the present invention. This software may be downloaded to the management and
`
`control component in electronic form over a network, for example, or it may alternatively
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`be supplied on tangible media, such as CD-ROM.
`
`The dose calculation system
`
`Reference
`
`is made
`
`to Fig. 5, which
`
`is a
`
`schematic
`
`illustration of
`
`radiopharmaceutical dose calculation system 152, in accordance with an embodiment of
`
`5
`
`the present invention. The dose calculation system manages and tracks, typically
`
`automatically, radiopharmaceutical inventory, ordering, dose dispensing, and disposal.
`
`Typically, the dose calculation system comprises one or more standard personal
`
`computers or servers with appropriate memory, communication interfaces and software
`
`for carrying out the functions prescribed by relevant embodiments of the present
`
`10
`
`invention. This software may be downloaded to the dose calculation system in electronic
`
`form over a network, for example, or it may alternatively be supplied on tangible media,
`
`such as CD-ROM. The dose calculation system receives information from dispensing
`
`system 20 regarding doses drawn from the inventory.
`
`Dose calculation system 152 typically comprises:
`
`15
`
`• an ordering sub-system 154, which orders radiopbarmaceutical products
`
`from
`
`radiopharmaceutical manufacturers,
`
`distributors,
`
`and/or
`
`radiopharmacies,
`
`typically automatically, such as when
`
`the dose
`
`calculation
`
`system
`
`identifies
`
`that
`
`inventories
`
`of
`
`a
`
`given
`
`radiopharmaceutical are lower than needed;
`
`20
`
`• a receipt and verification sub-system 155, which manages the receipt and
`
`registration of radiopharmaceutical products. The receipt and verification
`
`sub-system checks the received products against orders placed by the
`
`ordering sub-system, and typically performs license management. When a
`
`received mother vial 104 includes a mother vial data carrier 106, the
`
`25
`
`sub-system reads information contained in the data carrier to verify that
`
`the order has been accurately fulfilled, and, typically, verifies the
`
`authenticity of the mother vial;
`
`• a dose calculation sub-system 156, which calculates customized doses of
`
`labeled radiopham1aceutical agents for patients based on patient-specific
`
`30
`
`information, protocol information, and/or prescription information, and
`
`communicates the customized doses to patient management system 160
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`and/or dispensing system 20; and/or
`
`• a waste-disposal sub-system 157, which tracks radioactive waste disposal
`
`by system 10, such as disposal of radioactive materials contained in waste
`
`container 512, described hereinbelow with reference to Fig. 12. For some
`
`5
`
`applications, sub-system 157 additionally tracks radioactive waste disposal
`
`of materials in the clinical environment not associated with system 10.
`
`Ordering sub-system 154 and waste-disposal sub-system 157 typically operate in
`
`accordance with per country requirements for radiopharmaceutical use. A reporting
`
`sub-system reports to relevant nuclear regulatory commissions as required, based on
`
`10
`
`information obtained from the other sub-systems.
`
`In an embodiment of the present invention, dose calculation sub-system 156
`
`designs a cocktail of labeled radiopharrnaceutical agents or a series of labeled
`
`radiopharrnaceutical agents to carry out the desired imaging. When designing such a
`
`cocktail or series, the sub-system considers constraints imposed by the physical properties
`
`15
`
`of the agents and by the patient history, and other requirements, such as safety and
`
`efficacy requirements. The sub-system determines an appropriate dose for the specific
`
`patient having particular physiological parameters (e.g., weight, BMI, and age), and
`
`determines the times at which multiple agents are to be administered to the patient in
`
`order to achieve optimal imaging.
`
`20
`
`For some applications, sub-system 156 determines that a plurality of labeled
`
`radiopharrnaceutical agents are to be administered together and thus must be combined in
`
`a single preparation, i.e., a cocktail. For other applications, the sub-system determines
`
`that a plurality of labeled radiopharmaceutical agents are to be administered separately at
`
`different times and thus must be contained in separate containers 22. As appropriate,
`
`25
`
`sub-system 156 takes into consideration differing half-lives of the plurality of labeled
`
`radiopharmaceutical agents, in conjunction with the prescribed time of the imaging
`
`procedure. For example, a simultaneous imaging protocol is provided for assessing
`
`cardiac perfusion using a cocktail comprising Tc-99m sestamibi injected at rest, and
`
`thallium-201 injected at stress, wherein the desired activities at imaging time of the
`
`30
`
`Tc-99m sestamibi and the thallium are 6 mCi and 4 mCi, respectively. When calculating
`
`the necessary activity of the dispensed dose, sub-system 156 accounts for the respective
`
`half-lives of Tc-99m (6 hours) and thallium-201 (64 hours) in view of the planned time
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`interval between the dispensing time and administration time. For example, if dispensing
`
`is performed 24 hours before administration, sub-system 156 calculates the activities of
`
`the Tc-99m and thallium-201 at the time of dispensing to be 96 mCi and 5.5 mCi,
`
`respectively.
`
`5
`
`Protocol information
`
`Reference is made to Figs. 6A-E, which is a
`
`table showing exemplary
`
`preconfigured SPECT protocols and parameters thereof, in accordance with respective
`
`embodiments of the present invention. These protocols are appropriate, for example, for
`
`use with the SPECT imaging methods and apparatus described hereinbelow with
`
`10
`
`reference to Fig. 11, and/or in the co-assigned patent applications and/or patent
`
`application publications incorporated herein by reference hereinabove. For some
`
`applications, the techniques described herein utilize additional protocols described in
`
`above-mentioned
`
`International Application
`
`PCT/IL2005/001l73,
`
`International
`
`Application PCT/IL2005/001215, filed November 16, 2005, above-mentioned US
`
`15
`
`Provisional Patent Application 60/628,105, above-mentioned US Provisional Patent
`
`Application 60/675,892, or in one or more of the other co-assigned patent applications
`
`and/or patent application publications incorporated herein by reference. Alternatively or
`
`additionally, the techniques described herein utilize protocols for non-SPECT imaging
`
`modalities, such as PET or CT, or other imaging modalities known in the art. The
`preconfigured protocols are stored in a database, which is typically used by patient
`
`20
`
`management system 160 for suggesting protocols and/or by dose calculation sub-system
`
`156, as described hereinabove with reference to Figs. 4 and 5, respectively.
`
`For each of the exemplary protocols shown in Fig. 6A, the table indicates general
`
`parameters for a rest phase and a stress phase of the protocol. For example, for the "single
`isotope I low dose I fast imaging" protocol, the table shows that the radiopharmaceutical
`
`25
`
`(RP) for the rest phase of the protocol is less than 0.3 mCi of Thallium, that the waiting
`
`time after injection of the radiopharmaceutical is 2 minutes, and that the image acquisition
`
`duration is 15 minutes. Parameters for the stress phase are similarly indicated, with the
`
`addition of the type of stress (exercise, e.g., treadmill or bicycle, or pharmaceutical, e.g.,
`
`30
`
`adenosine). The "thallium stress perfusion" and 11simultaneous dual isotope stress
`
`perfusion" protocols are optionally dynamic.
`
`For each of the exemplary protocols shown in Figs. 6B-E, the table indicates
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`administration parameters, detector parameters, scanning parameters, and analysis
`
`parameters for the protocol. For example, for Protocol A of Figs. 6B-C ("Cardiac
`
`mapping"), the table indicates:
`
`5
`
`•
`
`•
`
`•
`
`•
`
`the labeled radiopharmaceutical agent is Tc-99-sestamibi (MIBI);
`
`the protocol is a fast protocol, with image acquisition completed prior to
`
`substantial uptake of the agent by the liver;
`
`the injection is by a single bolus;
`
`image acquisition begins either about 2 minutes after injection, or during
`
`or immediately administration, for applications in which the administration
`
`10
`
`is performed while the patient is already placed at camera 452 (Fig. 11);
`
`•
`
`the detected photon energy is 140 KeV with an energy resolution of 15%,
`
`i.e., the total range of energy levels detected by the detectors 454 of
`
`camera 452 (Fig. 11) is set to be 15% of the emitted energy level of the
`
`labeled radiopharmaceutical agent (140 Kev). Typically, this range is not
`
`15
`
`centered around the emitted energy level, but instead is shifted towards
`
`lower energy levels;
`
`the total scan time is 120 seconds;
`
`four detectors 454 of camera 452 are assigned as outer (distal) detectors,
`
`and six detectors 454 are assigned as inner (proximal) detectors, as
`
`•
`
`•
`
`20
`
`described hereinbelow with reference to Fig. 11;
`
`• each of the inner detectors has an angular range of between 90 and 120
`
`degrees, and each of the outer detectors has an angular range of between
`
`40 and 60 degrees;
`
`•
`
`the total number of angular orientations assumed by the detectors in
`
`25
`
`aggregate is 1200, i.e., 10 detectors times 120 orientations each;
`
`• each angular step of the inner detectors is one degree, and each angular
`
`step of the outer detectors is 0.3 to 0.5 degrees (corresponding to the range
`
`of 40 to 60 degrees described above); .
`
`•
`
`the dwell time at each step is one second, for both the inner and outer
`
`30
`
`detectors;
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`•
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`•
`
`the imaging procedure is gated using 16 to 32 frames;
`
`the analyses to be performed include intensity image and ejection fraction.
`
`For some applications, the protocol information includes additional information
`
`not shown in Figs. 6B-E, such as:
`
`5
`
`• additional scanning parameters, such as whether the detectors perform
`
`multiple scans (in all the protocols shown in the table, the detectors
`
`typically perform a single scan); and
`
`• additional analysis parameters, such as:
`
`• saturation handling (in the first cardiac mapping protocol shown in the
`
`10
`
`table, no saturation handling is performed, while in the second cardiac
`
`mapping protocol shown in the table, the analysis is configured to
`dismiss saturated pixels);
`
`• whether the analysis handles scatter from multiple sources (in the
`
`15
`
`protocols shown in the table, the analysis does not handle scatter from
`multiple sources);
`
`•
`
`reconstruction resolution (in all of the protocols shown in the table, the
`
`image reconstruction resolution is 2.5 mm in the z-direction, and 5 mm
`
`in the x- and y-directions); and
`
`• parameters that provide the diagnosis system (e.g., expert system) with
`
`20
`
`information regarding how to interpret the results of the imaging study,
`
`such as kinetic parameters, predefined pathological values, or
`
`patient-specific physiological parameters (e.g., BMI, age, or a group to
`
`which the patient is assigned).
`
`Reference is made to Protocol E of Figs. 6B-C. In this cardiac mapping protocol,
`
`25
`
`simultaneous image acquisition is performed using, typically using full conventional
`
`doses of both thallium and MIBI-Tc. The detected photon energy of the thallium is 167
`
`KeV, rather than the 72 KeV that is conventionally detected during nuclear imaging
`
`procedures. Unlike conventional SPECT cameras, the camera described hereinbelow with
`
`reference to Fig. 11 is sufficiently sensitive to detect a clinically-relevant count of the
`
`30
`
`relatively low percentage (8%) of photons emitted at the 167 Ke V energy level.
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`(Detection of 72 Ke V energy is generally, not practical when a conventional dose of
`
`MIBI-Tc is used, because the scatter from the 140 KeV energy level of MIBI-Tc masks
`
`the 72 KeV photons emitted by the thallium.)
`
`Reference is made to Protocol I of Figs. 6D-E. In this cardiac dynamic mapping
`protocol,
`image acquisition
`typically begins prior
`to administration of
`the
`
`5
`
`radiophannaceutical agent, such as at one minute prior to administration, as shown in the
`
`table. This allows the imaging system to complete one full scan of the region of interest
`
`prior to administration of the radiopharmaceutical agent, in order to ensure that the
`
`imaging system is able to acquire photons of radiation beginning immediately after the
`
`10
`
`radiopharmaceutical agent is administered.
`
`Typically, a selected preconfigured protocol is customized based on physiological
`
`parameters of the specific patient, and/or a medical profile group of the patient, as
`
`described hereinabove with reference to Fig. 4. Such customization typically includes
`
`customization of the radiopharmaceutical agent, administration parameters, and/or
`
`15
`
`imaging parameters.
`
`For some· applications, one or more of the following parameters of the
`
`radiopharmaceutical agent are customized:
`
`•
`
`•
`
`•
`
`•
`
`20
`
`the dose, or for multiple radiophannaceutical agents, the respective doses;
`
`the radioactivity;
`
`for cocktails, the ratio of the different radiopharmaceutical agents; and/or
`
`the volume of the dose, or for multiple radiopharmaceutical agents, the
`
`volumes of the respective doses.
`
`For some applications, one or more of the following parameters of the
`
`administration are customized:
`
`25
`
`•
`
`the dose administered, or for multiple radiophannaceutical agents, the
`
`respective doses per administration;
`
`•
`
`the type of administration, e.g., a single bolus, a plurality of boluses (e.g.,
`
`two boluses), pulsatile administration, or constant drip administration;
`
`•
`
`the labeled radiopharmaceutical agent for each administration, whether a
`
`30
`
`single agent or a cocktail of agents;
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`•
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`•
`
`the time of the administration with respect to the time of imaging;
`
`the timings of multiple administrations with respect to each other and with
`
`respect
`
`to other activities, such as rest or stress .(physical or
`
`pharmacological);
`
`5
`
`•
`
`the administration device, e.g., a syringe, a dual-needle syringe, a pump, or
`
`an IV line; and/or
`
`•
`
`the mode of administration, e.g., manual, automatic, or computer driven.
`
`For some applications, one or more of the following parameters of the imaging
`
`procedure are customized~ For some applications, such parameters are separately
`
`10
`
`specified for individual components of camera 452 of imaging system 28, or groups of
`
`components, such as for individual detectors 454 or groups of detectors of camera 452,
`
`described hereinbelow with reference to Fig. 11.
`
`•
`
`total acquisition time, and/or acquisition time for a plurality of phases of
`
`acquisition;
`
`15
`
`• detector scanning plan, including detector motions, such as detector
`
`angular and translational motions, detector step size (i.e., the density of the
`
`step size, typically expressed in degrees), number of detectors utilized for
`
`image acquisition, and detector dwell time at each view;
`
`• detector sensitivity;
`
`20
`
`• detection energy resolution;
`
`• detector calibration plan;
`
`• definition of the region of interest (ROI);
`
`• gating parameters;
`
`• energy bands, i.e., a plurality of non-overlapping energy windows;
`
`25
`
`• collimator positioning, shape, structure, and orientation;
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`• multiple/interlaced scans;
`
`• zooming parameters;
`
`• uniformity/non-uniformity of scan;
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`• Compton scatter map calculation and correction parameters;
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`• optimal energy window;
`
`• optimal energy resolution, i.e:, ·the range of energy level windows for
`
`which detection is enabled; and/or
`
`5
`
`• adaptivity of scan pattern to acquired counts, e.g., active vision parameters
`
`(as described m
`
`the above-mentioned
`
`International Application
`
`PCT/IL2005/001l73).
`
`In an embodiment of the present invention, system 10 uses high definition
`
`protocols in conjunction with SPECT imaging techniques to enable personalized
`
`10
`
`functional imaging at higher speeds and resolutions than can be achieved using
`
`conventional radiopharmaceutical protocols and imaging technology, using imaging
`
`techniques described herein and/or incorporated herein by reference. Alternatively or
`
`additionally, the system uses low dose protocols that enable personalized functional
`
`imaging at higher resolutions but with substantially lower doses than possible using
`
`15
`
`conventional methods.
`
`In an embodiment of the present invention, system 10 uses a protocol pursuant to
`which a patient undergoes a rest thallium (Tl-201-thallous chloride) and stress
`
`Tc-99-sestamibi (MIBI) study having a total study duration of between about 60 and
`
`about 90 minutes, and a total image acquisition duration of between about 0.5 and about 6
`
`20 minutes, e.g., about four minutes. For example, pursuant to the protocol:
`
`• about 3 mCi of thallium may be administered to the patient as a bolus IV
`
`injection,
`
`•
`
`the patient may rest for between about 10 and about 15 minutes,
`
`• an image acquisition having a duration of about two minutes may be
`
`25
`
`performed,
`
`•
`
`the patient may be physically stressed,
`
`• about 20-30 mCi of Tc-99-sestamibi may be administered as a bolus IV
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`injection, and
`
`• a second image acquisition having a duration of about two minutes may be
`
`30
`
`performed.
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`Such dual-isotope imaging is generally useful for assessing myocardial perfusion
`
`of patients with suspected ischemic syndromes and a variety of other conditions.
`
`Alternatively, in an embodiment, the rest phase is performed using an approximately 8 to
`
`10 mCi dose of Tc-99-sestamibi, in which case image acquisition typically commences
`
`5
`
`about 30 minutes after injection of the sestamibi.
`
`Further alternatively, in an
`
`embodiment, image acquisition for the rest phase is performed about two minutes after
`
`injection of the thallium, the stress is pharmacological (e.g., using adenosine ), and image
`
`acquisition for the stress phase is performed essentially immediately after injection of the
`
`sestamibi. Still further alternatively, in an embodiment, the rest phase is performed using
`
`10
`
`Tc-99-sestamibi, and image acquisition commences essentially immediately upon
`
`injection of a dose of about 8 to 10 mCi.
`
`In accordance with
`
`respective embodiments of the present
`
`invention,
`
`dual-radiopharmaceutical protocols include the administration and simultaneous imaging
`
`of the following combinations of labeled radiopharmaceutical agents. Typically, the
`
`15
`
`labeled radiopharmaceutical agents are administered as a mixture (i.e., a cocktail) before
`
`or
`
`during
`
`a
`
`simultaneous
`
`imaging
`
`procedure;
`
`alternatively,
`
`the
`
`labeled
`
`radiopharmaceutical agents are administered separately before or during a simultaneous
`
`imaging procedure.
`
`•
`
`(a) I-123 BMIPP, a fatty acid imaging agent that has been available in
`
`20
`
`Japan for many years, and is currently in Phase III clinical trials in the
`
`United States, and (b) a myocardial perfusion agent (e.g., Tc-99m
`
`sestamibi, Tc-99m
`
`tetrofosmin, or Tl-201-thallous chloride),
`
`for
`
`simultaneously studying myocardial perfusion and fatty acid metabolism;
`
`•
`
`(a) Tl-201-thallous chloride and
`
`(b) Tc-99m pertechnetate,
`
`for
`
`25
`
`differentiating an organ from its anatomical surroundings, such as
`
`differentiating parathyroid glands from the thyroid gland;
`
`•
`
`(a) In-111 DTPA, and (b) Tc-99m-MAG3, for differentiating pathological
`
`processes in a given organ, such as performing differential diagnosis of a
`
`hypo-perfused kidney, e.g., to study true glomerular filtration rate and
`
`30
`
`tubular secretion simultaneously;
`
`• a cocktail of labeled radiopharmaceutical agents, for studying cancer,
`
`including simultaneous diagnosis, prediction of therapy response, and
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`monitoring of therapy, such as simultaneously identifying a tumor, and
`characterizing tumor perfusion and metabolic activity, e.g., in order to
`provide a disease signature; and
`
`•
`
`the combinations shown in the following table.
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`TABLEl
`
`First
`radiopharmaceutical
`
`First application
`
`radiopharmaceutical
`
`application
`
`Second
`
`Second
`
`201Tl
`
`Myocardial
`
`Tc-99m-teboroxime
`
`Myocardial
`
`perfusion
`
`Tc-99m-sestamibi
`
`perfusion
`
`201TI
`
`201TI
`
`201TI
`
`Tc-99m-tetrophosmin
`
`Myocardial
`
`perfusion
`
`Tc-99m-PYP
`
`Infarct Imaging
`
`Myocardial
`
`Tc-99m-Annexin
`
`Apoptosis
`
`perfusion
`
`Myocardial
`
`perfusion
`
`123I-BMIPP
`
`Hypoxia
`
`Tc-99m-teboroxime
`
`Myocardial
`
`11 lrn-Annexin
`
`Apoptosis
`
`perfusion
`
`Tc-99m-teboroxime
`
`Myocardial
`
`123I-Fatty acid
`
`Metabolism
`
`1 llin-WBC
`
`perfusion
`
`Infection
`
`Tc-99m-SC
`
`Bone Marrow
`
`11 lin-DTP