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

June 5, 2025 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Healthy volunteers
Other: MRI acquisitions
MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.
Other: 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
Active Comparator: patients requiring radial forearm flap reconstruction
Other: MRI acquisitions
MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.
Other: 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
Experimental: patients having received hand allotransplantation
Other: MRI acquisitions
MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 0
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
day 0
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
day 0
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
day 0
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
day 0
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
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

Hôpital Edouard Herriot

Investigators

  • Principal Investigator: Olivier Baledent, MD, CHU Amiens
  • Principal Investigator: Marie-Antoinette Sevestre-Pietri, Pr, CHU Amiens
  • Principal Investigator: Emmanuel Morelon, Pr, Hôpital Edouard Herriot
  • Principal Investigator: Palmira Petruzzo, MD, Hôpital Edouard Herriot
  • Principal Investigator: Stéphanie Dakpe, MD, CHU Amiens
  • Principal Investigator: Jérémie Bettoni, MD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2019_843_0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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