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

NCT ID: NCT03806751

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Healthy volunteers
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[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.

Group Type EXPERIMENTAL

[O-15]Water

Intervention Type DRUG

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.

Acetazolamide

Intervention Type DRUG

The administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.

Interventions

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[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.

Intervention Type DRUG

Acetazolamide

The administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.

Intervention Type DRUG

Other Intervention Names

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Diamox

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Jonathan E McConathy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UAB Advanced Imaging Facility

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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R18-010

Identifier Type: -

Identifier Source: org_study_id

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