FLOWHAND: Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Healthy volunteers
|
Other: MRI acquisitions
MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.
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
|
| Active Comparator: patients requiring radial forearm flap reconstruction
|
Other: MRI acquisitions
MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.
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
|
| Experimental: patients having received hand allotransplantation
|
Other: MRI acquisitions
MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.
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
|
Outcome Measures
Primary Outcome Measures
- Variation of radial vascular flows between healthy volunteers and patients with forearm flap reconstruction [day 0]
Radial 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 reconstruction [day 0]
Ulnar 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 reconstruction [day 0]
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
- Variation of radial vascular flows between healthy volunteers and patients with hand allotransplantation [day 0]
Radial 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 allotransplantation [day 0]
Ulnar 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 allotransplantation [day 0]
Interdigital arterial tree vascular flows between healthy volunteers and patients with hand allotransplantation will be determined by using the specifically developed flow MRI protocol
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult (≥ 18 years old)
-
patients who has received appropriate information and provided informed consent
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patients benefiting from social security insurance
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patients with no contraindications to magnetic resonance imaging
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healthy volunteer or patient requiring radial forearm flap reconstruction or having received hand allotransplantation.
Exclusion Criteria:
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Person with a contraindication to MRI
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pregnant or breastfeeding woman
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minors (< 18 years)
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person under guardianship or deprived of liberty by a judicial or administrative decision
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person with upper limb arteriopathy with the exception of the hand transplant patients group.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Amiens | Amiens | France | 80480 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire, Amiens
- Hôpital Edouard Herriot
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI2019_843_0077