Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations (NCT00010452) | Clinical Trial Compass
CompletedPhase 2/3
Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
United States150 participantsStarted 2000-04
Plain-language summary
OBJECTIVES:
I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
Who can participate
Age range6 Months – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
* Diagnosis of macrocystic lymphangioma of the head and/or neck Cystic spaces at least 2.0 mL confirmed by radiographic imaging (MRI or CT) Mixed lymphangiomas (macrocystic and microcystic disease) allowed if macrocystic component comprises at least 50% of the total disease burden
* No mixed hemangioma-lymphangioma lesions
* At least 6 months since prior surgery for lymphangioma
--Patient Characteristics--
* Hematopoietic: No clinically significant hematologic disease No hemodynamic instability
* Hepatic: No clinically significant hepatic disorder
* Renal: No clinically significant renal disease No personal or family history of post-streptococcal glomerulonephritis
* Cardiovascular: No personal or family history of rheumatic heart disease
* Pulmonary: No respiratory failure
Other:
* Not pregnant or nursing
* Negative pregnancy test
* No history of allergy to penicillin
* No concurrent temperature of 100.5 degrees or greater
* No active upper respiratory infection
* No personal or family history of obsessive-compulsive or tic disorders
* No personal or family history of PANDA (pediatric autoimmune neuro- psychiatric disorder associated with streptococcal infections)
* No history of hypersensitivity to iodine, Omnipaque, or gadolinium (if fluoroscopy is considered necessary)
* No history of poor health (including congenital disorders, chronic diseases, or immunologic dysfunction)
What they're measuring
1
to establish whether OK432 sclerotherapy is an effective form of treatment for lymphatic malformations versus the traditional form of treatment, which is surgical excision.