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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Vascular Complications; Radial Artery; Transplantation; Magnetic Resonance Imaging

Treatments: Other: Doppler ultrasound procedure; Other: MRI acquisitions

Study type: Interventional

Funder types: Other

Identifiers

NCT04257747

PI2019_843_0077

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 3 patient groups

Healthy volunteers

Sham Comparator group

Treatment:

Other: MRI acquisitions

Other: Doppler ultrasound procedure

patients requiring radial forearm flap reconstruction

Active Comparator group

Treatment:

Other: MRI acquisitions

Other: Doppler ultrasound procedure

patients having received hand allotransplantation

Experimental group

Treatment:

Other: MRI acquisitions

Other: Doppler ultrasound procedure