Overview

This trial is active, not recruiting.

Conditions lymphoma, neuroblastoma, sarcoma
Treatments computed tomography, magnetic resonance imaging, positron emission tomography
Sponsor American College of Radiology Imaging Network
Collaborator National Cancer Institute (NCI)
Start date October 2004
End date December 2005
Trial size 226 participants
Trial identifier NCT00072488, ACRIN-6660, CDR0000339811

Summary

RATIONALE: New imaging procedures, such as whole-body MRI, may improve the ability to detect metastatic cancer and determine the extent of disease.

PURPOSE: This clinical trial is studying whole-body MRI to see how well it works compared to standard imaging procedures in detecting distant metastases in patients with solid tumors or lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose diagnostic

Eligibility Criteria

Male or female participants up to 21 years old.

DISEASE CHARACTERISTICS: - Confirmed diagnosis OR newly diagnosed mass strongly suspected to represent 1 of the following: - Rhabdomyosarcoma - Ewing's sarcoma family of tumors - Neuroblastoma - Hodgkin's lymphoma - Non-Hodgkin's lymphoma - All imaging examinations (e.g., CT scan, MRI, or scintigraphy) must be performed within 14 days of each other and within 2 months of any diagnostic or operative procedure - Whole body MRI and positron emission tomography (PET) scanning (if PET scan is being done) must be done before treatment - Prior CT scan, conventional MRI, bone scintigraphy, gallium scintigraphy, or meta-iodobenzylguanidine (MIBG) scintigraphy performed at outside institutions allowed provided the same technical standards specified in this study were practiced - Bone scintigraphy required for patients with neuroblastoma, rhabdomyosarcoma, or other sarcomas - Gallium scintigraphy not required in lymphoma patients if PET scan is performed - No CNS primary tumor PATIENT CHARACTERISTICS: Age - 21 and under Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No active cardiac pacemakers Other - Not pregnant or nursing - No prior malignancy - No uncontrolled diabetes mellitus (for patients undergoing optional PET) - Patients with controlled diabetes mellitus must have a fasting blood glucose no greater than 200 mg/dL - No contraindications to MRI or CT scan (e.g., intracranial vascular clips) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Prior biopsy or surgery allowed provided no more than 2 months has passed since the procedure

Additional Information

Official title Whole-Body MRI in the Evaluation of Pediatric Malignancies
Principal investigator Marilyn J. Siegel, MD
Description OBJECTIVES: Primary - Compare non-inferior diagnostic performance of whole-body MRI (i.e., combination of turbo short-tau inversion-recovery (STIR) and out-of-phase imaging) vs conventional imaging (i.e., the combination of chest CT scan, scintigraphy [bone, gallium, meta-iodobenzylguanidine (MIBG), or optional fludeoxyglucose F 18 positron emission tomography (FDG-PET)] and abdominal/pelvic CT scan/MRI as indicated) for detecting distant metastases for use in staging common tumors in pediatric patients. Secondary - Determine the incremental benefit of adding out-of-phase T1-weighted gradient-recalled echo imaging to turbo STIR for detecting distant disease in these patients. - Determine, preliminarily, the relative accuracies of FDG-PET, whole-body MRI, and a combination of FDG-PET and whole-body MRI in detecting stage IV disease in these patients. - Determine the effects of multiple factors, including cancer type, site of primary tumor, and patient age, on diagnostic accuracy of whole-body MRI in these patients. - Determine the interobserver variability associated with interpreting whole-body MRI exams for detecting distant metastases in these patients. OUTLINE: This is a multicenter study. Patients undergo conventional MRI, CT scan, and/or scintigraphy (e.g., bone, meta-iodobenzylguanidine [MIBG], or gallium) and experimental whole-body MRI sequences. Patients may optionally undergo fludeoxyglucose F18 positron emission tomography (FDG-PET). Patients with a lesion (or lesions) detected on whole-body MRI or FDG-PET at initial staging that are not confirmed by biopsy or other conventional imaging studies at staging repeat standard imaging at 3- to 6-month follow-up. Patients with an abnormality that is considered highly suspicious for a metastasis or when biopsy proof of that metastasis is obtained receive treatment at the discretion of the treating physician. Patients are followed annually for 3 years. PROJECTED ACCRUAL: A total of 226 patients (45 with neuroblastoma, 54 with rhabdomyosarcoma, 27 with other sarcoma, and 100 with lymphoma) will be accrued for this study within 1 year.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).