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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

NCT04257747 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-09-01
Last updated
2025-06-10

Condition(s) studied

Magnetic Resonance ImagingVascular ComplicationsTransplantationRadial Artery

Investigational drug(s) / intervention(s)

MRI acquisitionsDoppler ultrasound procedure

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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 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 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 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 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 sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04257747 on ClinicalTrials.gov ↗ ← All trials in France