Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations

Recruiting Phase 2 Interventional Study
Lymphatic Malformation Pediatric
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
Up to 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
28 (estimated)
Sponsor
University Hospital, Lille · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient from 0 to 18 years of age, presenting with poly-cystic suprahyoid or mediastinal lymphatic. * with chronic pain or functional respiratory or swallowing impairment with a CDS score \< 8 * Curative treatment is not possible or associated with a high risk of morbidity ,mo…
Contacts

Pierre Fayoux, MD

3 20 44 50 67

pierre.fayoux@chru-lille.fr

CONTACT