Carotid Artery StenosisPhase 2CAROTEPNCT03353103
Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy
A Phase 2 study testing Sodium fluoride F-18 PET imaging in people with Carotid Artery Stenosis, run by University Hospital, Caen at 1 site in France.
Trial summary
This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Sodium fluoride F-18 PET imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2018to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age over 18 years old
- Health care system affiliation
- Referred to carotid endarterectomy
- Symptomatic patients:
- Carotid stenosis between 70 and 99% (NASCET criteria)
- TIA or minor stroke attack (RANKIN ≤ 3)
Show all 10Show fewer
- Asymptomatic patients:
- Carotid stenosis between 70 and 99% (NASCET criteria)
- No symptoms
- Patient who has been informed of the study and has given his/her informed consent
Who cannot join
- Contra indication to MRI
- Renal failure (clearance < 30ml/mn)
- Patient with active inflammatory disease
- History of cancer
- Pregnancy or lactation
- Patient with carotid disease treated by fibrinolysis
- Patient under guardianship, or unable to understand the purpose of the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen
Lucie Camelière, +33231065161, cameliere-l@chu-caen.fr
About this study
Official title: Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study
This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components
- Conditions
- Carotid Artery Stenosis
- Being tested
- Sodium fluoride F-18 PET imaging
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium fluoride F-18 PET imagingDrug
prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging
| Study group | Role | What they receive |
|---|---|---|
| symptomatic | Active comparator | Not described Receives: Drug: Sodium fluoride F-18 PET imaging |
| asymptomatic | Active comparator | Not described Receives: Drug: Sodium fluoride F-18 PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid F18-NaF uptake
do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination
Measured: baseline
Secondary outcomes (3)
comparaison of F18-NaF PET and Carotid MRI
comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination
Measured: baseline
F18-NaF PET uptake
comparaison between F18-NaF uptake at pre-operative imaging
Measured: baseline
histology
comparaison between histology at post-operative histologic analysis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start3 Sep 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353103
- Sponsor's protocol ID
- 17-012
- Acronym
- CAROTEP
- Status last verified
- Jan 2020
- First submitted
- 14 Apr 2017
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study
- ClinicalTrials.gov ID
- NCT03353103
- Acronym / sponsor ID
- CAROTEP / 17-012
- Conditions
- Carotid Artery Stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 27 Nov 2017 (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 will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptomatic | Active comparator | Drug: Sodium fluoride F-18 PET imaging |
| asymptomatic | Active comparator | Drug: Sodium fluoride F-18 PET imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age over 18 years old
- Health care system affiliation
- Referred to carotid endarterectomy
- Symptomatic patients:
- Asymptomatic patients:
Key exclusion criteria (7 listed)
- Contra indication to MRI
- Renal failure (clearance < 30ml/mn)
- Patient with active inflammatory disease
- History of cancer
- Pregnancy or lactation
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 |
|---|---|---|
| Sodium fluoride F-18 PET imagingprior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging | Drug | asymptomatic, symptomatic |
Primary outcome
carotid F18-NaF uptake
Time frame: baseline
do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination
3 secondary outcomes
comparaison of F18-NaF PET and Carotid MRI
Time frame: baseline
F18-NaF PET uptake
Time frame: baseline
histology
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium fluoride F-18 PET imaging in people with Carotid Artery Stenosis, run by University Hospital, Caen 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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie Cameliere, MD (+33231065161, cameliere-l@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid F18-NaF uptake (time frame: baseline). 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 13 Jan 2020.