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WithdrawnNCT03806751O-15 WaterUpdated Mar 1, 2024

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

An Early Phase 1 interventional study of [O-15]Water and Acetazolamide in Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging, sponsored by University of Alabama at Birmingham. Withdrawn at 1 site in United States. Open to participants aged 19 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.

Sponsored by University of Alabama at Birmingham · Early Phase 1, Interventional, and Basic science

Why this study was withdrawn
The investigator decided not to pursue the study.
Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
19 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

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

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
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

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.
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Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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 · Drug: Acetazolamide

Interventions

  • 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.

  • DrugAcetazolamide

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

    Also known as: Diamox

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

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Study locations

1 site
  • UAB Advanced Imaging Facility
    Birmingham, Alabama 35294, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03806751
Lead sponsor
University of Alabama at Birmingham
Responsible party
Jonathan E McConathy (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Jan 16, 2019
Start date
Feb 1, 2025 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Mar 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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