A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning (O-15 Water)
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| ClinicalTrials.gov Identifier: NCT03806751 |
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Recruitment Status :
Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : March 12, 2021
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Sponsor:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging | Drug: [O-15]Water Drug: Acetazolamide | Early Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 6 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Healthy volunteers |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning |
| Estimated Study Start Date : | February 1, 2022 |
| Estimated Primary Completion Date : | February 1, 2024 |
| Estimated Study Completion Date : | February 1, 2024 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Acetazolamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: [O-15]water PET/MRI
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.
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Drug: [O-15]Water
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. Drug: Acetazolamide The administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.
Other Name: Diamox |
Primary Outcome Measures :
- Comparison of arterial sampling to non-invasive methods to measure regional cerebral blood flow using [O-15]water-PET/MRI [ Time Frame: 3 years ]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.
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| Ages Eligible for Study: | 19 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806751
Contacts
| Contact: Jonathan McConathy, MD, PhD | 205-934-6504 | jmcconathy@uabmc.edu | |
| Contact: April Riddle, RT | 205-934-6504 | ariddle@uabmc.edu |
Locations
| United States, Alabama | |
| The Kirklin Clinic | |
| Birmingham, Alabama, United States, 35249 | |
| UAB Advanced Imaging Facility | |
| Birmingham, Alabama, United States, 35294 | |
Sponsors and Collaborators
University of Alabama at Birmingham
| Responsible Party: | Jonathan E McConathy, Principal Investigator, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT03806751 |
| Other Study ID Numbers: |
R18-010 |
| First Posted: | January 16, 2019 Key Record Dates |
| Last Update Posted: | March 12, 2021 |
| Last Verified: | March 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Acetazolamide Anticonvulsants Carbonic Anhydrase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Physiological Effects of Drugs |