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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06584747
Acronym
DIAMOX-TEP
Enrollment
19
Registered
2024-09-05
Start date
2025-01-09
Completion date
2027-04-09
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Circulation

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.

Interventions

DIAGNOSTIC_TESTPET scan

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.

Sponsors

Centre Antoine Lacassagne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
diagnostic performance of the 18F-FDG PET12 monthsThe 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

MeasureTime frameDescription
contribution of late 18F-FDG PET metabolic information12 monthsTo 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026