Cerebrovascular CirculationDIAMOX-TEPNCT06584747
Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy
A study testing PET scan in people with Cerebrovascular Circulation, run by Centre Antoine Lacassagne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Circulation
- What is being tested?
- PET scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2025to 9 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebrovascular Circulation
- Being tested
- PET scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arms | Experimental | Not described Receives: Diagnostic Test: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance of the 18F-FDG PET
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.
Measured: 12 months
Secondary outcomes (1)
contribution of late 18F-FDG PET metabolic information
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start9 Jan 2025
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584747
- Sponsor's protocol ID
- 2024/27
- Acronym
- DIAMOX-TEP
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy
- ClinicalTrials.gov ID
- NCT06584747
- Acronym / sponsor ID
- DIAMOX-TEP / 2024/27
- Conditions
- Cerebrovascular Circulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arms | Experimental | Diagnostic Test: PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scan18F-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. | Diagnostic test | Experimental Arms |
Primary outcome
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.
1 secondary outcome
contribution of late 18F-FDG PET metabolic information
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET scan in people with Cerebrovascular Circulation, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance of the 18F-FDG PET (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.