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

NCT03806751 — Early Phase 1, Withdrawn, University of Alabama at Birmingham

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Registry	NCT03806751, acronym O-15 Water
Status	Withdrawn - The investigator decided not to pursue the study.
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, basic science
Sponsor	University of Alabama at Birmingham (Other)
Conditions	Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging
Interventions	[O-15]Water, Acetazolamide (Drug)
Dates	start 2025-02-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2019-01-16, last updated 2024-03-01
Locations	1 site in United States

-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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+Arms and interventions

Arm	Type	Interventions	Description
[O-15]water PET/MRI	Experimental	Drug: [O-15]Water; Drug: 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.

[O-15]Water (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 (Drug), also known as Diamox: The administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 19 Years to 60 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
UAB Advanced Imaging Facility	Birmingham, Alabama	United States

My Notes

Public

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