Magnetic Resonance ImagingFLOWHANDNCT04257747
Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI
A study testing MRI acquisitions and Doppler ultrasound procedure in people with Magnetic Resonance Imaging and Vascular Complications, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Vascular Complications, Transplantation
- What is being tested?
- MRI acquisitions and Doppler ultrasound procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Stéphanie Dakpe, MD, (33)322089050, dakpe.stephanie@chu-amiens.fr
Sylvie Testelin, Pr, (33)322089050, testelin.sylvie@chu-amiens.fr
About this study
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.
- Being tested
- MRI acquisitions, Doppler ultrasound procedure
- Keywords
- vascularized composite allotransplantation, hand allotransplantation, radial forearm flap, magnetic resonance imaging, flow MRI, radial artery, ulnar artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI acquisitionsOther
MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.
Doppler ultrasound procedureOther
The Doppler ultrasound procedure will be conducted in the traditional way in the Vascular Medicine Department of the Amiens-Picardie University Hospital
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Sham comparator | Not described Receives: Other: MRI acquisitions; Other: Doppler ultrasound procedure |
| patients requiring radial forearm flap reconstruction | Active comparator | Not described Receives: Other: MRI acquisitions; Other: Doppler ultrasound procedure |
| patients having received hand allotransplantation | Experimental | Not described Receives: Other: MRI acquisitions; Other: Doppler ultrasound procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 0
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
Measured: day 0
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
Measured: day 0
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
Measured: day 0
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
Measured: day 0
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
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Sep 2021
- Primary completionMay 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Edouard Herriot
- Responsible party
- Sponsor
- Investigators
- Stéphanie Dakpe, MD, Principal investigator, CHU AmiensJérémie Bettoni, MD, Principal investigator, CHU AmiensOlivier Baledent, MD, Principal investigator, CHU AmiensMarie-Antoinette Sevestre-Pietri, Pr, Principal investigator, CHU AmiensEmmanuel Morelon, Pr, Principal investigator, Hopital Edouard HerriotPalmira Petruzzo, MD, Principal investigator, Hopital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257747
- Sponsor's protocol ID
- PI2019_843_0077
- Acronym
- FLOWHAND
- Status last verified
- Jun 2025
- First submitted
- 4 Feb 2020
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04257747
- Acronym / sponsor ID
- FLOWHAND / PI2019_843_0077
- Keywords
- vascularized composite allotransplantation, hand allotransplantation, radial forearm flap, magnetic resonance imaging, flow MRI, radial artery, ulnar artery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Hôpital Edouard Herriot
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Sham comparator | Other: MRI acquisitions, Other: Doppler ultrasound procedure |
| patients requiring radial forearm flap reconstruction | Active comparator | Other: MRI acquisitions, Other: Doppler ultrasound procedure |
| patients having received hand allotransplantation | Experimental | Other: MRI acquisitions, Other: Doppler ultrasound procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI acquisitionsMRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces. | Other | Healthy volunteers, patients having received hand allotransplantation, patients requiring radial forearm flap reconstruction |
| Doppler ultrasound procedureThe Doppler ultrasound procedure will be conducted in the traditional way in the Vascular Medicine Department of the Amiens-Picardie University Hospital | Other | Healthy volunteers, patients having received hand allotransplantation, patients requiring radial forearm flap reconstruction |
Primary outcome
Variation of radial vascular flows between healthy volunteers and patients with forearm flap reconstruction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie Dakpe, MD principal investigator
CHU Amiens
Jérémie Bettoni, MD principal investigator
CHU Amiens
Olivier Baledent, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI acquisitions and Doppler ultrasound procedure in people with Magnetic Resonance Imaging and Vascular Complications, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie testelin, Pr ((33)322089070, testelin.sylvie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of radial vascular flows between healthy volunteers and patients with forearm flap reconstruction (time frame: day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.