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

NCT ID: NCT04257747

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Magnetic Resonance Imaging Vascular Complications Transplantation Radial Artery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy volunteers

Group Type SHAM_COMPARATOR

MRI acquisitions

Intervention Type OTHER

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

Doppler ultrasound procedure

Intervention Type OTHER

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

patients requiring radial forearm flap reconstruction

Group Type ACTIVE_COMPARATOR

MRI acquisitions

Intervention Type OTHER

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

Doppler ultrasound procedure

Intervention Type OTHER

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

patients having received hand allotransplantation

Group Type EXPERIMENTAL

MRI acquisitions

Intervention Type OTHER

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

Doppler ultrasound procedure

Intervention Type OTHER

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

Interventions

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MRI acquisitions

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital Edouard Herriot

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphanie Dakpe, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Jérémie Bettoni, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Olivier Baledent, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Marie-Antoinette Sevestre-Pietri, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Emmanuel Morelon, Pr

Role: PRINCIPAL_INVESTIGATOR

Hopital Edouard Herriot

Palmira Petruzzo, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Edouard Herriot

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sylvie testelin, Pr

Role: CONTACT

(33)322089070

Bernard Devauchelle, Pr

Role: CONTACT

(33)322089070

Facility Contacts

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Stéphanie Dakpe, MD

Role: primary

(33)322089050

Sylvie Testelin, Pr

Role: backup

(33)322089050

Other Identifiers

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PI2019_843_0077

Identifier Type: -

Identifier Source: org_study_id

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