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

Not Applicable

Recruiting

• Conditions: Radial Artery; Vascular Complications; Transplantation; Magnetic Resonance Imaging
• Interventions: Other: MRI acquisitions; Other: Doppler ultrasound procedure

• Registration Number: NCT04257747
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Study Start: 2021-09-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Doppler ultrasound procedure	-
Healthy volunteers	MRI acquisitions	-
patients having received hand allotransplantation	Doppler ultrasound procedure	-
patients requiring radial forearm flap reconstruction	MRI acquisitions	-
patients requiring radial forearm flap reconstruction	Doppler ultrasound procedure	-
patients having received hand allotransplantation	MRI acquisitions	-

Primary Outcome Measures

Name	Time	Method
Variation of ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction	day 0	Ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol
Variation of radial vascular flows between healthy volunteers and patients with forearm flap reconstruction	day 0	Radial vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol
Variation of radial vascular flows between healthy volunteers and patients with hand allotransplantation	day 0	Radial vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol
Variation of ulnar artery vascular flows between healthy volunteers and patients with hand allotransplantation	day 0	Ulnar artery vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol
Variation of interdigital arterial tree vascular flows between healthy volunteers and patients with forearm flap reconstruction	day 0	Interdigital arterial tree vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol
Variation of interdigital arterial tree vascular flows between healthy volunteers and patients with hand allotransplantation	day 0	Interdigital arterial tree vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France