Clinical trial NCT04257747: Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI
Official title: Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Hôpital Edouard Herriot
First posted: 2020-02-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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 outcomes:
measure: Variation of radial vascular flows between healthy volunteers and patients with forearm flap reconstruction
timeFrame: day 0
measure: Variation of ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction
timeFrame: day 0
measure: Variation of interdigital arterial tree vascular flows between healthy volunteers and patients with forearm flap reconstruction
timeFrame: day 0
measure: Variation of radial vascular flows between healthy volunteers and patients with hand allotransplantation
timeFrame: day 0
measure: Variation of ulnar artery vascular flows between healthy volunteers and patients with hand allotransplantation
timeFrame: day 0
measure: Variation of interdigital arterial tree vascular flows between healthy volunteers and patients with hand allotransplantation
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Stéphanie Dakpe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Jérémie Bettoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Olivier Baledent, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Marie-Antoinette Sevestre-Pietri, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Edouard Herriot
name: Emmanuel Morelon, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Edouard Herriot
name: Palmira Petruzzo, MD
role: PRINCIPAL_INVESTIGATOR
References: