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

NCT ID: NCT06584747

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Cerebrovascular Circulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental Arms

Group Type EXPERIMENTAL

PET scan

Intervention Type 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.

Interventions

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PET 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Antoine Lacassagne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Antoine Lacassagne

Nice, , France

Site Status

Countries

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France

Central Contacts

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Study coordinator

Role: CONTACT

+33 04 92 03 16 61

Facility Contacts

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Study coordinator

Role: primary

Other Identifiers

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2024/27

Identifier Type: -

Identifier Source: org_study_id

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