Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 7:22 AM
Study NCT ID:
NCT03806751
Status:
WITHDRAWN
Last Update Posted:
2024-03-01
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Healthy volunteers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The investigator decided not to pursue the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of arterial sampling to non-invasive methods to measure regional cerebral blood flow using [O-15]water-PET/MRI', 'timeFrame': '3 years', 'description': 'Measurements of regional cerebral blood flow with \\[O-15\\]water-PET/MRI using arterial sampling versus non-invasive image-based input function estimates will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging']}, 'descriptionModule': {'briefSummary': 'The overall aim of this project is to implement a non-invasive method of measuring quantitative regional cerebral blood flow (rCBF) on the UAB hybrid PET/MRI scanner to allow conducting such \\[O-15\\]water based scans with relative ease and safety in a large variety of important clinical and research applications. Participants will undergo imaging at baseline and after administration of a drug to increase cerebral blood flow to evaluate perfusion estimates during low and high flow states. The goal of this study is to generate data that will justify eliminating invasive arterial sampling in most \\[O-15\\]water-based PET protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Six participants aged 19-60 years of age, male and female, with no evidence of neurological disease, will be recruited from UAB and the surrounding community.\n\nExclusion Criteria:\n\n* Participants will be excluded if there is any evidence or history of claustrophobia or the subject has metallic implants or devices that are normally exclusion factors for MRI.'}, 'identificationModule': {'nctId': 'NCT03806751', 'acronym': 'O-15 Water', 'briefTitle': 'A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning', 'orgStudyIdInfo': {'id': 'R18-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[O-15]water PET/MRI', 'description': 'Volunteers will have two brain PET/MRI scans; first scan after injection of \\[O-15\\]water; second scan after injection of 1 gram of acetazolamide followed by injection of \\[O-15\\]water.', 'interventionNames': ['Drug: [O-15]Water', 'Drug: Acetazolamide']}], 'interventions': [{'name': '[O-15]Water', 'type': 'DRUG', 'description': 'All study participants with undergo brain imaging with \\[O-15\\]water-PET/MRI without and with administration of the carbonic anhydrase inhibitor acetazolamide. The PET tracer will be used to measure regional cerebral perfusion, and the administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.', 'armGroupLabels': ['[O-15]water PET/MRI']}, {'name': 'Acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox'], 'description': 'The administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.', 'armGroupLabels': ['[O-15]water PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Advanced Imaging Facility', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jonathan E McConathy', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}