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

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

— O-15 Water  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03806751
• Other study ID #: R18-010
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: February 1, 2025
• Est. completion date: February 1, 2027

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	UAB Advanced Imaging Facility	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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