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

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.

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jonathan McConathy, MD, PhD; Phone Number: 205-934-6504; Email: jmcconathy@uabmc.edu
• Study Contact Backup: Name: April Riddle, RT; Phone Number: 205-934-6504; Email: ariddle@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Advanced Imaging Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of arterial sampling to non-invasive methods to measure regional cerebral blood flow using [O-15]water-PET/MRI	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.	3 years

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Acetazolamide
• Other Study ID Numbers: R18-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No