Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging
- Conditions
- Localized Resectable NeuroblastomaPrecancerous ConditionAdrenocortical Carcinoma
- Interventions
- Procedure: computed tomographyProcedure: 3-Tesla magnetic resonance imagingProcedure: 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
-
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
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
Rainbow Babies and Childrens Hospital
🇺🇸Cleveland, Ohio, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Alfred I duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Childrens Memorial Hospital
🇺🇸Chicago, Illinois, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Mission Hospitals Inc
🇺🇸Asheville, North Carolina, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Naval Medical Center - Portsmouth
🇺🇸Portsmouth, Virginia, United States
Saint Joseph's Regional Medical Center
🇺🇸Paterson, New Jersey, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
T C Thompson Children's Hospital
🇺🇸Chattanooga, Tennessee, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Chedoke-McMaster Hospitals
🇨🇦Hamilton, Ontario, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Ste-Foy, Quebec, Canada
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
East Tennessee Childrens Hospital
🇺🇸Knoxville, Tennessee, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
🇺🇸New Hyde Park, New York, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
Hospital Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
University of Rochester
🇺🇸Rochester, New York, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States