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Clinical Trials/NCT04257747
NCT04257747
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country46 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Magnetic Resonance Imaging
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
46
Locations
1
Primary Endpoint
Variation of ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
March 2029
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Variation of ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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