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Recruiting NCT04257747

NCT04257747 Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI

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Clinical Trial Summary
NCT ID NCT04257747
Status Recruiting
Phase
Sponsor Centre Hospitalier Universitaire, Amiens
Condition Magnetic Resonance Imaging
Study Type INTERVENTIONAL
Enrollment 46 participants
Start Date 2021-09-01
Primary Completion 2028-05

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
MRI acquisitionsDoppler ultrasound procedure

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 46 participants in total. It began in 2021-09-01 with a primary completion date of 2028-05.

⚠ 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

Allotransplants of vascularized composite tissues are subject to chronic vascular rejection, which can lead to graft loss. Currently, no imaging technique allows a reproducible quantitative exploration of the arterial trees of the hand, and therefore a satisfactory monitoring of transplants. Since 2014, flow MRI has been applied to the analysis of small-calibre arteries by the Image Processing Team at the Amiens-Picardie University Hospital. Between 2015 and 2017, several acquisitions were made in 3 patients who received facial allotransplantation, and the team recently developed a flow MRI protocol dedicated to the study of arterial trees in the hand. The main objective is to measure vascular flows of radial, ulnar and interdigital arterial trees in normal (healthy volunteers) and pathological situations (patients with radial forearm flap reconstruction and patients with hand allotransplantation) using the specifically developed flow MRI protocol.

Eligibility Criteria

Inclusion Criteria: * Adult (≥ 18 years old) * patients who has received appropriate information and provided informed consent * patients benefiting from social security insurance * patients with no contraindications to magnetic resonance imaging * healthy volunteer or patient requiring radial forearm flap reconstruction or having received hand allotransplantation. Exclusion Criteria: * Person with a contraindication to MRI * pregnant or breastfeeding woman * minors (\< 18 years) * person under guardianship or deprived of liberty by a judicial or administrative decision * person with upper limb arteriopathy with the exception of the hand transplant patients group.

Contact & Investigator

Central Contact

Sylvie testelin, Pr

✉ testelin.sylvie@chu-amiens.fr

📞 (33)322089070

Principal Investigator

Stéphanie Dakpe, MD

PRINCIPAL INVESTIGATOR

CHU Amiens

Frequently Asked Questions

Who can join the NCT04257747 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Magnetic Resonance Imaging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04257747 currently recruiting?

Yes, NCT04257747 is actively recruiting participants. Contact the research team at testelin.sylvie@chu-amiens.fr for enrollment information.

Where is the NCT04257747 trial being conducted?

This trial is being conducted at Amiens, France.

Who is sponsoring the NCT04257747 clinical trial?

NCT04257747 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is Stéphanie Dakpe, MD at CHU Amiens. The trial plans to enroll 46 participants.

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