Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-31 @ 3:48 PM
Study NCT ID:
NCT00733460
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2008-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for 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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-06', 'studyFirstSubmitDate': '2008-08-12', 'studyFirstSubmitQcDate': '2008-08-12', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure. Safety Biodistribution Radiation dosimetry', 'timeFrame': 'pre-dose, post-dose 0, 1, 5, 15, 30, 60 and 90 minutes, 2 hours, 24-48 hours post-dose and 7 days post-dose.', 'description': 'Change in vital signs, physical examination, ECG measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose.\n\nChange in 12-lead Electrocardiogram measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose.\n\nChange in 24-hour Holter (initiated 2 hours pre-dose, continuous for 24 hours, time stop recorded.\n\nChange in dosimetry sampling (blood and urine)blood measured at time 0 (immediately following injection), 1,5, 15, 30, 60, 90 minutes.\n\nAdverse event assessment immediate post dose, 24-48 hours and 7 days post-dose.'}], 'secondaryOutcomes': [{'measure': 'Performance characteristics of BFPET as a PET tracer for myocardial imaging.', 'timeFrame': '30, 60, 120, and 240 seconds.', 'description': 'Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BFPET', 'Coronary Artery Disease', 'Myocardial Perfusion Imaging', 'Radiation Dosimetry'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.', 'detailedDescription': 'Study Procedures:\n\nVisit 1: Screening - Eligibility determination\n\nVisit 2 (within 14 days post screening): Injection of BFPET™ and PET Imaging\n\nVisit 3 (within 24-48 hours post dose): Follow-up Visit'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "NORMAL HEALTHY VOLUNTEERS Inclusion Criteria\n\n1. Subject must provide written informed consent prior to any study related procedures;\n2. Subject must be ≥ 20 and ≤ 80 years of age;\n3. Subject must have a serum creatinine within the investigational site's normal range.\n4. Subject must have liver function tests \\< 1.5 times the investigational site's normal range.\n5. Subject must have a hematocrit level within 5% of the investigational site's normal range.\n\nExclusion Criteria:\n\n1. Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination;\n2. Any clinically significant abnormality in the screening laboratory tests or ECG;\n3. Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;\n4. Any exposure to investigational radiopharmaceuticals within four (4) weeks prior to the date of Visit 1;\n5. Any new prescription medications within four (4) weeks of Visit 1;\n6. Subject has a Positive (+) Serum Pregnancy Test, or the possibility of pregnancy cannot be ruled out prior to dosing or is breast-feeding. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH.\n7. Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents.\n\nCORONARY ARTERY DISEASE (CAD) SUBJECTS\n\nInclusion Criteria:\n\n1. Subjects must provide written informed consent prior to any study related procedures;\n2. Subjects must be ≥ 20 and ≤ 80 years of age;\n3. Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria\n\nExclusion Criteria:\n\n1. Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;\n2. Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;\n3. Coronary artery bypass graft (CABG) within 6 months;\n4. Percutaneous coronary intervention (PCI), with stent placement within six months;\n5. Blood pressure over 180/100;\n6. Acute changes in ECG;\n7. Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;\n8. Any implanted pacemaker or defibrillator use within the last three months;\n9. Inability to remain in camera for approximately 60 minutes (Smokers and COPD are included as long as they can breath in PET camera and not taking O2 through nasal canula);\n10. History of Diabetes Mellitus;\n11. Serum creatinine \\> 2 mg/dL;\n12. All cancer patients;\n13. Body Mass Index (BMI) is over 35;\n14. Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;\n15. Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;"}, 'identificationModule': {'nctId': 'NCT00733460', 'briefTitle': 'A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fluoropharma, Inc.'}, 'officialTitle': 'A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of BFPET as a Potential Myocardial Perfusion Imaging (MPI) Agent for PET', 'orgStudyIdInfo': {'id': 'BFPET P-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BF-PET', 'interventionNames': ['Drug: BFPET']}], 'interventions': [{'name': 'BFPET', 'type': 'DRUG', 'armGroupLabels': ['BF-PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Henry Gewirtz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fluoropharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}