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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Whole-Body MRI in the Evaluation of Pediatric Malignancies

Conditions
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Lymphoma, Neuroblastoma, Sarcoma

Intervention / Treatment
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* Procedure: computed tomography
* Procedure: magnetic resonance imaging
* Procedure: positron emission tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: computed tomography|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: positron emission tomography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma, previously untreated childhood rhabdomyosarcoma, stage I childhood Hodgkin lymphoma, stage I childhood large cell lymphoma, stage I childhood lymphoblastic lymphoma, stage I childhood small noncleaved cell lymphoma, stage II childhood Hodgkin lymphoma, stage II childhood large cell lymphoma, stage II childhood lymphoblastic lymphoma, stage II childhood small noncleaved cell lymphoma, stage III childhood Hodgkin lymphoma, stage III childhood large cell lymphoma, stage III childhood lymphoblastic lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood Hodgkin lymphoma, stage IV childhood large cell lymphoma, stage IV childhood lymphoblastic lymphoma, stage IV childhood small noncleaved cell lymphoma, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, previously treated childhood rhabdomyosarcoma