Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
- Conditions
- Lymphatic Malformations
- Registration Number
- NCT00010452
- Lead Sponsor
- University of Iowa
- Brief Summary
OBJECTIVES:
I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
- Detailed Description
PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment (no prior treatment vs prior surgical treatment) and geographic area.
Patients who meet all study criteria are put in the "Immediate Treatment Group." Patients receive an intralesional injection of picibanil (OK432) with the aid of ultrasonography or transillumination for localization of cysts. Treatment repeats every 6-8 weeks for a total of up to 4 injections.
After completion of treatment, patients are followed at 6 months, 1 year, and 2 years.
Completion date provided represents the completion date of the grant per OOPD records
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method to establish whether OK432 sclerotherapy is an effective form of treatment for lymphatic malformations versus the traditional form of treatment, which is surgical excision. indefinate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Children's Associated Medical Group
🇺🇸San Diego, California, United States
Children's Hospital of Denver
🇺🇸Denver, Colorado, United States
Childrens National Medical Center
🇺🇸Washington, District of Columbia, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Children's Hospitals and Clinics - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Texas Pediatric Otolaryngology Center
🇺🇸Houston, Texas, United States
Scroll for more (3 remaining)Children's Associated Medical Group🇺🇸San Diego, California, United States