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NCT Number: NCT04257747

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

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.

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Key information

Conditions

Magnetic Resonance Imaging Radial Artery Transplantation Vascular Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI acquisitions

Other

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

Doppler ultrasound procedure

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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 contacts

Contact information is provided by the study sponsor or research team.

Bernard Devauchelle, Pr

CONTACT

[email protected]

(33)322089070

Sylvie testelin, Pr

CONTACT

[email protected]

(33)322089070

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Hôpital Edouard Herriot

Registry information

Acronym: FLOWHAND

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Feb 6, 2020
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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