O-15 Water: A Noninvasive Arterial Input Estimation Method for O-15 PET and Integrated PET/MR Scanning

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03806751

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Healthy volunteersHealthy 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

Anticipated Study Start Date :

Feb 1, 2024

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

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 Names: Diamox

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 Names:

Diamox

Outcome Measures

Primary Outcome Measures

Comparison of arterial sampling to non-invasive methods to measure regional cerebral blood flow using [O-15]water-PET/MRI [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Kirklin Clinic	Birmingham	Alabama	United States	35249
2	UAB Advanced Imaging Facility	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan E McConathy, Principal Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03806751

Other Study ID Numbers:

R18-010

First Posted:

Jan 16, 2019

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acetazolamide

Study Results

No Results Posted as of Mar 31, 2022