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

NCT04257747 | Recruiting

• 1 other identifier: PI2019_843_0077
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Resonance Imaging; Vascular Complications; Transplantation; Radial Artery

Keywords

vascularized composite allotransplantation; hand allotransplantation; radial forearm flap; magnetic resonance imaging; flow MRI; radial artery; ulnar artery

Outcome Measures

Primary Outcomes (6)

• 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

  day 0

• 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

  day 0

• 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

  day 0

• 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

  day 0

• Variation of ulnar artery vascular flows between healthy volunteers and patients with hand allotransplantation

  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

  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

Study Arms (3)

Healthy volunteers

SHAM COMPARATOR

Other: MRI acquisitions; Other: Doppler ultrasound procedure

patients requiring radial forearm flap reconstruction

ACTIVE COMPARATOR

Other: MRI acquisitions; Other: Doppler ultrasound procedure

patients having received hand allotransplantation

EXPERIMENTAL

Other: MRI acquisitions; Other: Doppler ultrasound procedure

Interventions

MRI acquisitions OTHER

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

Healthy volunteers; patients having received hand allotransplantation; patients requiring radial forearm flap reconstruction

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

Healthy volunteers; patients having received hand allotransplantation; patients requiring radial forearm flap reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Hôpital Edouard Herriot: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Study Officials

• Stéphanie Dakpe, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Jérémie Bettoni, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Olivier Baledent, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Marie-Antoinette Sevestre-Pietri, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Emmanuel Morelon, Pr

  Hopital Edouard Herriot

  PRINCIPAL INVESTIGATOR

• Palmira Petruzzo, MD

  Hopital Edouard Herriot

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie testelin, Pr

CONTACT

(33)322089070; testelin.sylvie@chu-amiens.fr

Bernard Devauchelle, Pr

CONTACT

(33)322089070; devauchelle.bernard@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: September 1, 2021
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)