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

Study Overview
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Brief Summary
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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.

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

Conditions
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Magnetic Resonance Imaging, Vascular Complications, Transplantation, Radial Artery

Intervention / Treatment
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* Other: MRI acquisitions
* Other: Doppler ultrasound procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Healthy volunteers<br> | Other: MRI acquisitions<br>* MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.<br>Other: Doppler ultrasound procedure<br>* The Doppler ultrasound procedure will be conducted in the traditional way in the Vascular Medicine Department of the Amiens-Picardie University Hospital<br>|
| Active Comparator: patients requiring radial forearm flap reconstruction<br> | Other: MRI acquisitions<br>* MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.<br>Other: Doppler ultrasound procedure<br>* The Doppler ultrasound procedure will be conducted in the traditional way in the Vascular Medicine Department of the Amiens-Picardie University Hospital<br>|
| Experimental: patients having received hand allotransplantation<br> | Other: MRI acquisitions<br>* MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.<br>Other: Doppler ultrasound procedure<br>* The Doppler ultrasound procedure will be conducted in the traditional way in the Vascular Medicine Department of the Amiens-Picardie University Hospital<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flow MRI, vascularized composite allotransplantation, hand allotransplantation, radial forearm flap, magnetic resonance imaging, radial artery, ulnar artery