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

Completed

• Conditions: Localized Resectable Neuroblastoma; Precancerous Condition; Adrenocortical Carcinoma
• Interventions: Procedure: computed tomography; Procedure: 3-Tesla magnetic resonance imaging; Procedure: Abdominal Sonogram

• Registration Number: NCT00445718
• Lead Sponsor: Children's Oncology Group

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	computed tomography	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.
Observational	3-Tesla magnetic resonance imaging	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.
Observational	Abdominal Sonogram	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.

Primary Outcome Measures

Name	Time	Method
Survival rate	Up to 3 years	Estimated using the Kaplan-Meier method.
Event-free survival (EFS)	Up to 3 years	Estimated using the Kaplan-Meier method.

Trial Locations

Locations (45)

University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

Southern California Permanente Medical Group; 🇺🇸 Downey, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Alfred I duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Baptist Hospital of Miami; 🇺🇸 Miami, Florida, United States

Childrens Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States

Southern Illinois University; 🇺🇸 Springfield, Illinois, United States

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