Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging

Study Overview
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Brief Summary
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This natural history study is collecting health information about infants with adrenal masses found on prenatal and/or neonatal imaging. 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.

Detailed Description
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PRIMARY OBJECTIVE: I. 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%. SECONDARY OBJECTIVES: I. Estimate the percentage of these patients who are spared surgical resection. II. Evaluate the natural history and histology of perinatal adrenal masses. III. Evaluate the tumor biology and histology of prenatal and neonatal neuroblastomas. IV. 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 protocol therapy. After a patient goes off-observation, they will be monitored every six months for two years, and annually thereafter.

Official Title
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Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study

Conditions
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Adrenocortical Carcinoma, Localized Resectable Neuroblastoma, Precancerous Condition

Intervention / Treatment
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* Procedure: computed tomography
* Procedure: 3-Tesla magnetic resonance imaging
* Procedure: Abdominal Sonogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sonographically identified adrenal mass meeting one of the following criteria: No greater than 16 mL in volume, if solid No greater than 65 mL if at least 25% cystic and does not cross the midline Disease limited to the adrenal gland No evidence of positive contralateral or ipsilateral lymph nodes or other spread outside the adrenal gland by CT scan or MRI No evidence of disease outside the adrenal gland by MIBG scan Negative for tumor cells by bone marrow biopsy, if performed No more than 6 months of age on the date the mass is first identified No prior chemotherapy No prior abdominal surgery

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>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 protocol therapy. | Procedure: computed tomography<br> <br> * Other names: tomography, computed;Procedure: 3-Tesla magnetic resonance imaging<br> <br> * Other names: 3T MRI;Procedure: Abdominal Sonogram<br>* Sonogram of the abdomen area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Estimated using the Kaplan-Meier method. | Up to 3 years | 
| Event-free survival (EFS) | Estimated using the Kaplan-Meier method. | Up to 3 years |