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

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.

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Key information

Conditions

Cerebrovascular Circulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine Lacassagne

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Acronym: DIAMOX-TEP

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 5, 2024
Registry last updated: May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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