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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04257747
Acronym
FLOWHAND
Enrollment
46
Registered
2020-02-06
Start date
2021-09-01
Completion date
2029-03-31
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging, Radial Artery, Transplantation, Vascular Complications

Keywords

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

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.

Interventions

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

OTHERDoppler ultrasound procedure

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

Sponsors

Hôpital Edouard Herriot
CollaboratorOTHER
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Variation of radial vascular flows between healthy volunteers and patients with forearm flap reconstructionday 0Radial vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol
Variation of ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstructionday 0Ulnar artery vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol
Variation of interdigital arterial tree vascular flows between healthy volunteers and patients with forearm flap reconstructionday 0Interdigital arterial tree vascular flows between healthy volunteers and patients with forearm flap reconstruction will be determined by using the specifically developed flow MRI protocol
Variation of radial vascular flows between healthy volunteers and patients with hand allotransplantationday 0Radial vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol
Variation of ulnar artery vascular flows between healthy volunteers and patients with hand allotransplantationday 0Ulnar artery vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol
Variation of interdigital arterial tree vascular flows between healthy volunteers and patients with hand allotransplantationday 0Interdigital arterial tree vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol

Countries

France

Contacts

Primary ContactSylvie testelin, Pr
testelin.sylvie@chu-amiens.fr(33)322089070
Backup ContactBernard Devauchelle, Pr
devauchelle.bernard@chu-amiens.fr(33)322089070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026