NCT00072488

Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma

Whole-Body MRI in the Evaluation of Pediatric Malignancies

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lymphoma
• Neuroblastoma
• Sarcoma

Interventions

Type	Name	Description
PROCEDURE	computed tomography
PROCEDURE	magnetic resonance imaging
PROCEDURE	positron emission tomography

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-12-01
• First posted: 2003-11-06
• Last updated: 2010-06-08

Locations

21 sites across 2 countries: United States, Canada