Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging
RATIONALE: Gathering information over time from imaging and laboratory tests of infants with adrenal masses may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging.
Procedure: computed tomography
Procedure: magnetic resonance imaging
|Official Title:||Perinatal Neuroblastoma: Expectant Observation - A Children's Oncology Group Pilot Study|
- 3-year survival rate
- Natural history and histology of disease
- Tumor biology and histology of prenatal and neonatal neuroblastomas
- Tumor characteristics associated with a need for resection
|Study Start Date:||March 2005|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
- Determine whether nonoperative management of infants with adrenal masses found on prenatal and/or neonatal imaging results in a 3-year survival rate of 95%.
- Estimate the percentage of these patients who are spared surgical resection.
- Evaluate the natural history and histology of perinatal adrenal masses.
- Evaluate the tumor biology and histology of prenatal and neonatal neuroblastomas.
- Determine the tumor characteristics that are associated with a need for resection.
OUTLINE: Patients undergo an abdominal CT or MRI scan on weeks 0, 6, and 42 and an abdominal sonogram on weeks 0, 3, 6, 12, 18, 30, 42, 66, and 90. Urinary catecholamine levels are also measured on the same weeks as the abdominal sonogram. Patients with an increase in tumor volume or catecholamine levels undergo sonographic evaluation and urine catecholamine sampling every 3 weeks until stabilization. Patients with a continued increase in catecholamine levels or a 50% increase in tumor volume undergo surgical resection off study.
Patients are followed within 1 week and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.