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

Magnetic Resonance Imaging Clinical Trial

— FLOWHAND  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257747
• Other study ID #: PI2019_843_0077
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 2029

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Sylvie testelin, Pr
• Phone: (33)322089070
• Email: testelin.sylvie[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: March 2029
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Radial Artery
• Transplantation
• Vascular Complications

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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