Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
|ClinicalTrials.gov Identifier: NCT00072488|
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 6, 2003
Last Update Posted : June 8, 2010
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.
|Condition or disease||Intervention/treatment|
|Lymphoma Neuroblastoma Sarcoma||Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: positron emission tomography|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||226 participants|
|Masking:||None (Open Label)|
|Official Title:||Whole-Body MRI in the Evaluation of Pediatric Malignancies|
|Study Start Date :||October 2004|
|Estimated Primary Completion Date :||December 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072488
Show 21 Study Locations
|Principal Investigator:||Marilyn J. Siegel, MD||Mallinckrodt Institute of Radiology at Washington University Medical Center|