Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-05 @ 5:37 PM
Study NCT ID:
NCT01993303
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2012-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Comparison of 2D Cardiac PET With 3D Cardiac PET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-20', 'studyFirstSubmitDate': '2012-08-01', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Accuracy', 'timeFrame': '1 day', 'description': 'To establish the quantitative accuracy of reconstructed volumes using Imagen3DTM when compared to other methods.'}, {'measure': 'Visual Assessment', 'timeFrame': '1 day', 'description': 'To establish that visual assessments of image quality and reader confidence using 3D data are equivalent to the other methods.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myocardial Perfusion Imaging', 'PET', 'Rb-82'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Lowering the per-infusion dose of Rb-82 offers advantages of lessening radiation exposure and extending useable generator life. Prior studies have not shown equivalence of 3D vs 2D Rb-82 PET. The investigators therefore compare 3D PET after a lower Rb-82 dose (\\~20 mCi) processed using a Monte-Carlo driven scatter correction algorithm against conventional higher dosage (\\~50 mCi) 2D Rb-82 PET MPI.', 'detailedDescription': 'This study re-examines 2D an 3D myocardial perfusion PET data from 19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male. Rest and stress scans were acquired on a Siemens Accel™ PET scanner in 2D (septa extended) and 3D (septa retracted) modes. Rb-82 doses were rest 53+/-5 mCi and stress 53+/-6 mCi. Imaging times were 2D emission scan for 3 mins (90 sec delay post Rb-82 infusion), followed by a 3 minute, 3D gated emission scan (180 sec delay). Decay and shorter acquisition times led to a 62% reduction in the effective dosage 2D vs 3D datasets. 3D images were first pre-processed using a Monte-Carlo scatter and prompt gamma correction algorithm (Imagen3D™) then reconstructed using ImagenProTM (CVIT, Kansas City, MO). Reconstructed images were evaluated using relative, 17 segment raw scores (Cedars QPET). Studies were read by consensus of 2-blinded readers for: image quality (1-4, poor-excellent), interpretive certainty (1-3, low-high) and rest perfusion using a 17 segment model (0=normal; 1-3 = mild, moderate, or severe perfusion defects). Stress segmental scores were not evaluated due to differences in imaging start time post dipyridamole infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 Years of Age\n* Have ability to provide informed consent\n* Have a technically adequate rest/stress Rb-82 perfsion PET study within the past 60 days\n\nExclusion Criteria:\n\n* Pregnant or nursing feamle\n* Weight \\> 275 lbs\n* Have contraindications to adenosine stress testing\n* Unstable cardiac rhythm (atrial fibrillation, frequent PVCs\n* PTCA or CABG within the last 60 days'}, 'identificationModule': {'nctId': 'NCT01993303', 'briefTitle': 'Direct Comparison of 2D Cardiac PET With 3D Cardiac PET', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiovascular Imaging Technologies'}, 'officialTitle': 'Direct Comparison of 2D Cardiac PET With 3D Cardiac PET Using a 3D Monte-Carlo Scatter COrrection Algorithm', 'orgStudyIdInfo': {'id': 'CVIT-01-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Cohort', 'description': 'Population: 19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male. Radionuclide Dosage: Rb-82 doses were rest 53+/-5 mCi and stress 53+/-6 mCi All were stress with Dipyridamole.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Lukes Hospital', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular Imaging Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}