Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
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|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||Phase|
|Lymphoma Neuroblastoma Sarcoma||Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: positron emission tomography||Not Applicable|
- 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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072488
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|Principal Investigator:||Marilyn J. Siegel, MD||Mallinckrodt Institute of Radiology at Washington University Medical Center|