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

Children's Oncology Group

Status: Completed

Conditions: Precancerous Condition; Adrenocortical Carcinoma; Localized Resectable Neuroblastoma

Treatments: Procedure: computed tomography; Procedure: Abdominal Sonogram; Procedure: 3-Tesla magnetic resonance imaging

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00445718

NCI-2009-00398 (Registry Identifier)

ANBL00P2

U10CA098543 (U.S. NIH Grant/Contract)

COG-ANBL00P2 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 97 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

97 participants in 1 patient group

Observational

Description:

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.

Treatment:

Procedure: 3-Tesla magnetic resonance imaging

Procedure: computed tomography

Procedure: Abdominal Sonogram