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Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma Clinical research trials and Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma. Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma  Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma
Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma
For Condition: Lymphatic Diseases,Cardiovascular Abnormalities,Lymphangioma
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of Iowa
Synopsis: OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
Details: PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment (no prior treatment vs prior surgical treatment) and geographic area. Patients are randomized to 1 of 2 treatment arms. Arm I (Immediate treatment group): Patients receive an intralesional injection of picibanil with the aid of ultrasonography, transillumination, or fluoroscopy for localization of cysts. Treatment repeats every 6-8 weeks for a total of 4 injections. Arm II (Delayed treatment group): Patients are observed for 24-26 weeks with lesion size measured every 6-8 weeks. At the conclusion of the observation period, patients receive picibanil as in arm I. Patients with life-threatening lymphangiomas receive treatment immediately as in arm I with the option of surgical rescue. Patients are followed at 6 months, 1 year, and 2 years.
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 6 Months/18 Years
Genders: Both
Protocol Entry Criteria: 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 - Patients who require emergency treatment are eligible but not entered into randomization --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)
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
RichardSmith, Study Chair, University of Iowa
Children's Hospitals and Clinics - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55404
United States
Recruiting Bruce Bostrom 612-813-6282
Children's Associated Medical Group *Recruiting*
San Diego, California, 92123
United States
Recruiting Anthony Magit 858-966-5934
Children's Hospital of the Kings Daughter *Recruiting*
Norfolk, Virginia, 23507
United States
Recruiting Craig Derkay 757-668-9853
Children's Hospital of Alabama *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Keith Georgeson 205-939-9285
University of Wisconsin Hospital and Clinics *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting Scott McMurray 608-262-7187
Children's Hospital of Wisconsin *Recruiting*
Milwaukee, Wisconsin, 53201
United States
Recruiting Joseph Kerschner 414-266-6486
Children's Hospital of Denver *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Peggy Kelly 303-764-8520
Texas Pediatric Otolaryngology Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Joe Edmonds 713-796-2001
University of Iowa Hospitals and Clinics *Recruiting*
Iowa City, Iowa, 52242
United States
Recruiting Richard Smith 319-356-2177
Additional Information:
Study ID Numbers: 199/15706; UIHC-FDR001774
Study Start Date: April 2000
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010452
Other Lymphatic Diseases Studies:
1. Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma
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Randomized Study of Picibanil Sclerotherapy in Children With Macrocystic Lymphangioma
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