A Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations
There is an unsatisfied medical need for a first-line treatment of lymphatic malformations with a good benefit/risk profile. Based on a patient experience in the institution, the investigators plan to verify whether or not the medication sildenafil has a beneficial effect on lymphatic malformations. The investigators plan to do this by treating patients with lymphatic malformations with the medication sildenafil for a 20 week period. This is an investigator initiated study funded by an Innovations in Patient Care grant and a SPARK grant.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Investigational Pilot Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations|
- Change in Volume of Lymphatic Malformation [ Time Frame: Baseline, 20 weeks ] [ Designated as safety issue: Yes ]Magnetic Resonance Imaging (MRI) was performed prior to initiation of sildenafil and after 20 weeks of sildenafil. MRI was used to calculate the volume of lymphatic malformations before and after sildenafil.
|Study Start Date:||December 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290484
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Alfred T Lane, MD||Stanford University|