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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
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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 : December 31, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 :
  1. 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
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Contact: Jonathan McConathy, MD, PhD 205-934-6504 jmcconathy@uabmc.edu
Contact: April Riddle, RT 205-934-6504 ariddle@uabmc.edu

Locations
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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

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Responsible Party: Jonathan E McConathy, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03806751     History of Changes
Other Study ID Numbers: R18-010
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019

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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