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

Early Phase 1

Withdrawn

• Conditions: Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging
• Interventions: Drug: [O-15]Water; Drug: Acetazolamide

• Registration Number: NCT03806751
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01
• Study Start: 2025-02-01
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[O-15]water PET/MRI	[O-15]Water	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.
[O-15]water PET/MRI	Acetazolamide	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UAB Advanced Imaging Facility; 🇺🇸 Birmingham, Alabama, United States