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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI acquisitions

    Other intervention

    MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.

  • Doppler ultrasound procedure

    Other intervention

    The Doppler ultrasound procedure will be conducted in the traditional way in the Vascular Medicine Department of the Amiens-Picardie University Hospital

Treatment groups

46 Participants
are divided into 3 treatment groups
Group A: Healthy volunteersSham comparator 2 interventions
Group B: patients requiring radial forearm flap reconstructionActive comparator 2 interventions
Group C: patients having received hand allotransplantationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
day 0
2

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

Time frame
day 0
3

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

Time frame
day 0
4

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

Time frame
day 0

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Hôpital Edouard Herriot

Collaborator