Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-02-23 @ 7:59 PM
Study NCT ID:
NCT02927327
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2016-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation Of MP26 Features in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011877', 'term': 'Radionuclide Imaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.strohmeyer@ge.com', 'phone': '609-865-7423', 'title': 'John Strohmeyer', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were reported from the time the subject entered the PET/MR suite until the subject left the PET/MR suite, an average of less than 2 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'PET/MR ZTE MRAC', 'description': 'PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.\n\nZero Echo Time (ZTE) scan for head attenuation\n\nZero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.\n\nPET/MR ZTE MRAC', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PET/MR Q Static (Q. MRAC)', 'description': 'Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.\n\nPET/MR Q Static (Q. MRAC)\n\nQ.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.\n\nPET/MR Q Static (Q. MRAC)', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Image Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PET/MR ZTE MRAC', 'description': 'PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.\n\nZero Echo Time (ZTE) scan for head attenuation\n\nZero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.\n\nPET/MR ZTE MRAC'}, {'id': 'OG001', 'title': 'PET/MR Q Static (Q. MRAC)', 'description': 'Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.\n\nPET/MR Q Static (Q. MRAC)\n\nQ.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.\n\nPET/MR Q Static (Q. MRAC)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'scored on a 5-pt Likert scale:\n\n1. Unacceptable\n2. Poor\n3. Acceptable\n4. Good\n5. Excellent', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that had a clinical indication for PET/CT or PET/MR with radiotracer injection prescribed for their medical care outside of the study.'}, {'type': 'SECONDARY', 'title': 'Determination of Diagnostic Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PET/MR ZTE MRAC', 'description': 'PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.\n\nZero Echo Time (ZTE) scan for head attenuation\n\nZero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.\n\nPET/MR ZTE MRAC'}, {'id': 'OG001', 'title': 'PET/MR Q Static (Q. MRAC)', 'description': 'Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.\n\nPET/MR Q Static (Q. MRAC)\n\nQ.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.\n\nPET/MR Q Static (Q. MRAC)'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'Site level determination of diagnostic acceptability (Y/N) based on consensus between radiologist(s) and nuclear medicine physician(s) at the site. Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.'}, {'type': 'SECONDARY', 'title': 'Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PET/MR ZTE MRAC', 'description': 'PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.\n\nZero Echo Time (ZTE) scan for head attenuation\n\nZero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.\n\nPET/MR ZTE MRAC'}, {'id': 'OG001', 'title': 'PET/MR Q Static (Q. MRAC)', 'description': 'Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.\n\nPET/MR Q Static (Q. MRAC)\n\nQ.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.\n\nPET/MR Q Static (Q. MRAC)'}], 'classes': [{'title': 'Prescribing PET scan', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Prescribing MR scans simultaneous with PET', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Starting and monitoring scanning', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Reviewing PET and MR images', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Overall process of doing this exam', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Performing exam within acceptable duration to meet', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'Ease of use ratings, based on a 5-point Likert scale (e.g. 1=unacceptable, 2=poor, 3=acceptable, 4=good, 5=excellent), were collected from the population of subjects who completed the study.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting "Yes" On All Binary Performance Scale Questions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PET/MR ZTE MRAC', 'description': 'PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.\n\nZero Echo Time (ZTE) scan for head attenuation\n\nZero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.\n\nPET/MR ZTE MRAC'}, {'id': 'OG001', 'title': 'PET/MR Q Static (Q. MRAC)', 'description': 'Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.\n\nPET/MR Q Static (Q. MRAC)\n\nQ.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.\n\nPET/MR Q Static (Q. MRAC)'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'The number of participants reporting "yes" on a binary performance scale (Y/N) were collected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Functionality ratings, based on a binary performance scale (Y/N), were collected from the population of subjects who completed the study, including both ZTE and Q.Static populations (N=61 total subjects).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Summary of Safety Information', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'Number of safety events (AEs and SAEs).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PET/MR ZTE MRAC', 'description': 'PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.\n\nZero Echo Time (ZTE) scan for head attenuation\n\nZero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.\n\nPET/MR ZTE MRAC'}, {'id': 'FG001', 'title': 'PET/MR Q Static (Q. MRAC)', 'description': 'Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.\n\nPET/MR Q Static (Q. MRAC)\n\nQ.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.\n\nPET/MR Q Static (Q. MRAC)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PET/MR ZTE MRAC', 'description': 'PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.\n\nZero Echo Time (ZTE) scan for head attenuation\n\nZero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.\n\nPET/MR ZTE MRAC'}, {'id': 'BG001', 'title': 'PET/MR Q Static (Q. MRAC)', 'description': 'Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.\n\nPET/MR Q Static (Q. MRAC)\n\nQ.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.\n\nPET/MR Q Static (Q. MRAC)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '12.86', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '10.76', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '12.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-30', 'size': 2019937, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-25T14:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2016-10-04', 'resultsFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-05', 'studyFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Summary of Safety Information', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'Number of safety events (AEs and SAEs).'}], 'primaryOutcomes': [{'measure': 'Diagnostic Image Quality', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'scored on a 5-pt Likert scale:\n\n1. Unacceptable\n2. Poor\n3. Acceptable\n4. Good\n5. Excellent'}], 'secondaryOutcomes': [{'measure': 'Determination of Diagnostic Acceptability', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'Site level determination of diagnostic acceptability (Y/N) based on consensus between radiologist(s) and nuclear medicine physician(s) at the site. Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.'}, {'measure': 'Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'Ease of use ratings, based on a 5-point Likert scale (e.g. 1=unacceptable, 2=poor, 3=acceptable, 4=good, 5=excellent), were collected from the population of subjects who completed the study.'}, {'measure': 'Number of Participants Reporting "Yes" On All Binary Performance Scale Questions', 'timeFrame': 'through study completion, an average of 2 months', 'description': 'The number of participants reporting "yes" on a binary performance scale (Y/N) were collected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Imaging', 'Whole Body Imaging']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to collect representative clinical images (head and whole-body scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device equipped with investigational software components in adult population. The images and summary data from this study are intended for use in regulatory submission.', 'detailedDescription': 'Primary Objective: To demonstrate diagnostic image quality of image sets with ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR in representative clinical cases of the general imaging population.\n\nSecondary Objective(s): To verify diagnostic acceptability, ease of use, and functionality of ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR at clinical sites.\n\nSafety Objective(s): To collect information about safety events and device issues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are adults (aged 18 or older);\n2. Have preexisting clinical indication for PET/CT or PET/MR with radiotracer injection (for subjects that will undergo ZTE procedures, a preexisting clinical indication for PET/CT is required);\n3. Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;\n4. Can hear without assistive devices and have necessary mental capacity to follow study instructions;\n5. Are willing and able to provide written informed consent;\n6. Are considered eligible for MRI and PET exams, according to site institutional safety policies.\n\nExclusion Criteria:\n\n1. Were previously enrolled in the study;\n2. If female, are pregnant or of undetermined pregnancy status;\n3. Cannot fit safely in the device (\\>55 cm axial diameter or \\>227 kgs body weight);\n4. Have implants or attached medical devices that could be unsafe for MRI;\n5. Have medical conditions or require urgent care that could make it unsafe to participate'}, 'identificationModule': {'nctId': 'NCT02927327', 'briefTitle': 'Clinical Evaluation Of MP26 Features in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Clinical Evaluation Of MP26 Features in Adults', 'orgStudyIdInfo': {'id': '114.03-2016-GES-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET/MR ZTE MRAC', 'description': 'PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.\n\nZero Echo Time (ZTE) scan for head attenuation', 'interventionNames': ['Device: Zero Echo Time (ZTE) scan for head attenuation']}, {'type': 'EXPERIMENTAL', 'label': 'PET/MR Q Static (Q. MRAC)', 'description': 'Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.\n\nPET/MR Q Static (Q. MRAC)', 'interventionNames': ['Device: Q.Static (Q. MRAC) for respiratory motion correction']}], 'interventions': [{'name': 'Zero Echo Time (ZTE) scan for head attenuation', 'type': 'DEVICE', 'description': 'The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.\n\nPET/MR ZTE MRAC', 'armGroupLabels': ['PET/MR ZTE MRAC']}, {'name': 'Q.Static (Q. MRAC) for respiratory motion correction', 'type': 'DEVICE', 'description': 'An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.\n\nPET/MR Q Static (Q. MRAC)', 'armGroupLabels': ['PET/MR Q Static (Q. MRAC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Tibor Duliskovich, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GE Healthcare, Medical Monitor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}