Skip to main content
Clinical Trials/NCT06584747
NCT06584747
Not yet recruiting
Not Applicable

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

Centre Antoine Lacassagne1 site in 1 country22 target enrollmentOctober 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Circulation
Sponsor
Centre Antoine Lacassagne
Enrollment
22
Locations
1
Primary Endpoint
diagnostic performance of the 18F-FDG PET
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2024
End Date
October 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

diagnostic performance of the 18F-FDG PET

Time Frame: 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 Outcomes

  • contribution of late 18F-FDG PET metabolic information(12 months)

Study Sites (1)

Loading locations...

Similar Trials