Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations
NCT03243019 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2026-05-22
Summary
To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.
The success rate is determined by volume reduction superior to 1/5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.
Conditions
- Lymphatic Malformation
- Pediatric
Interventions
- DRUG
-
oral administration
- DEVICE
-
MRI
cervicofacial MRI
- BIOLOGICAL
-
Rapamycin dosage
Biological dosage of Rapamycin level
Sponsors & Collaborators
-
Ministry of Health, France
collaborator OTHER_GOV -
University Hospital, Lille
lead OTHER
Principal Investigators
-
Pierre Fayoux, MD · University Hospital, Lille
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-25
- Primary Completion
- 2027-02-28
- Completion
- 2027-02-28
Countries
- France
Study Locations
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