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

Not Applicable

Not yet recruiting

• Conditions: Cerebrovascular Circulation

• Registration Number: NCT06584747
• Lead Sponsor: Centre Antoine Lacassagne

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05
• Study Start: 2024-10
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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.

Exclusion Criteria

• 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®).
• Patient enrolled in another clinical study with a specified exclusion period.
• Minor patient.
• Patient unable to give informed consent.
• Vulnerable individuals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
diagnostic performance of the 18F-FDG PET	12 months	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.

Secondary Outcome Measures

Name	Time	Method
contribution of late 18F-FDG PET metabolic information	12 months	To study the contribution of late 18F-FDG PET metabolic information: Late 18F-FDG PET metabolic images will be analyzed using Scenium® software, which enables stereotaxic normalization and the expression of uptake in terms of standard deviations relative to a database of normal subjects. The corresponding values will be compared based on the clinical progression of patients after revascularization.

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France