Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy

NCT06584747 | Active Not Recruiting

• 1 other identifier: 2024/27
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two methods for assessing brain blood flow. PET scan will be use with a drug called Acetazolamide and compare its effectiveness to the standard scintigraphy method. The goal is to see if the PET scan is just as good as the traditional method in measuring how well the brain's blood vessels respond to the drug.

Conditions

Cerebrovascular Circulation

Outcome Measures

Primary Outcomes (1)

• diagnostic performance of the 18F-FDG PET

  The primary endpoint is the sensitivity of the examination in detecting a decrease in cerebral vascular reserve (CVR). The presence or absence of a decrease in CVR for each patient will be determined by clinical consensus, based in particular on spontaneous follow-up (clinical progression, cerebral ischemic episodes, etc.) and/or on the progression after revascularization in cases where it is performed.

  12 months

Secondary Outcomes (1)

• contribution of late 18F-FDG PET metabolic information

  12 months

Study Arms (1)

Experimental Arms

EXPERIMENTAL

Diagnostic Test: PET scan

Interventions

PET scan DIAGNOSTIC_TEST

18F-FDG PET scans will be performed to assess cerebral vascular reserve. For exams involving stimulation with Acetazolamide (DIAMOX®), the radiopharmaceutical injection (18F-FDG or 99mTc-HMPAO) will start exactly 15 minutes after the Acetazolamide (DIAMOX®) injection.

Experimental Arms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic stenosing cerebral vascular pathology (stenosis \> 70% on Doppler examination or angiography).
• Patient aged over 18 years.
• Patient who has voluntarily agreed to participate in the study and has signed the written informed consent.
• Patient affiliated with a social security system.

You may not qualify if:

• Patient with stenosis less than 70% on Doppler examination or angiography.
• Patient with a contraindication to 18F-FDG PET examinations: severe claustrophobia, poorly controlled diabetes during 18F-FDG PET examinations (fasting capillary blood glucose ≥ 11 mmol/L).
• Patient with a contraindication to scintigraphy.
• Patient with an allergy to sulfonamides (Acetazolamide DIAMOX®).
• Minor patient.
• Patient unable to give informed consent.
• Vulnerable individuals

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06000, France

Location

MeSH Terms

Interventions

Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 5, 2024
• Study Start: January 9, 2025
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 9, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (1)