NCT02829190 Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries
| NCT ID | NCT02829190 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Carotid Artery, External |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2014-01-06 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2014-01-06 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The phase-contrast MRI offers the advantage to combine precisely vascular flow measurements data with morphological images. Even if the anatomy of the external carotid artery is well known, data obtained through Phase contrast MRI could permit to progress in several fields of cranio-maxillofacial surgery as for example arteriovenous malformations,radionecrosis, head and neck micro-reconstructive surgery. The aim of this study is to establish and develop Phase-contrast MRI sequences for vascular flow characterization branches of the external carotid artery in healthy patients and in pathological cases.
Eligibility Criteria
Inclusion Criteria: * group 1 : healthy volunteer * group 2 : X-Ray treatment antecedent (at least 50 grays and older than one year) * group 3 : antecedent of embolization of branches of external carotid artery * group 4 : antecedent of muscular free flap surgery (older than one month) * free and informed consent Exclusion Criteria: * group 1 : facial pathology, antecedent of facial injury, antecedent of X-Ray treatment in head and neck localisation, antecedent of head and neck cancer * group 2 : antecedent of surgery for head and neck cancer or for vascular disease * group 3 : antecedent of surgery for head and neck cancer or for vascular disease ; antecedent of X-Ray treatment. * group 4 : antecedent of surgery for head and neck cancer or for vascular disease ; antecedent of X-Ray treatment or embolization * patient with guardianship or trusteeship * MRI cons-indications * pregnancy and lactation
Contact & Investigator
Bernard DEVAUCHELLE, MD, phD
PRINCIPAL INVESTIGATOR
Amiens University Hospital
Frequently Asked Questions
Who can join the NCT02829190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Carotid Artery, External. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02829190 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT02829190 currently recruiting?
Yes, NCT02829190 is actively recruiting participants. Contact the research team at dakpe.stephanie@chu-amiens.fr for enrollment information.
Where is the NCT02829190 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT02829190 clinical trial?
NCT02829190 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is Bernard DEVAUCHELLE, MD, phD at Amiens University Hospital. The trial plans to enroll 80 participants.