Diffusion Weighted Magnetic Resonance in Imaging Younger Patients with Newly Diagnosed Bone or Soft Tissue Sarcomas

Status: closed to accrual

This clinical trial studies diffusion weighted magnetic resonance imaging (DW-MRI) in imaging younger patients with newly diagnosed bone or soft tissue sarcomas. Diagnostic procedures, such as DW-MRI, may help measure a patient's response to treatment. DW-MRI also does not use any radiation and may eliminate the need for exposing patients to harmful radiation by replacing imaging studies that do use radiation.

Inclusion Criteria

All St Jude patients with a known or suspected, newly diagnosed bone or soft-tissue sarcoma who will be treated on or as per disease specific protocols
Study subjects will have undergone or are scheduled for PET-CT and/or bone scan within about 2 weeks of the WB and primary tumor DWI MRI
Informed consent or assent signed by study subject or parent/guardian according to institutional guidelines
Patients should not have begun therapy, or, needed research imaging can be performed within 2-5 days of starting therapy

Exclusion Criteria

Subject has a tumor that will undergo upfront resection
Subject is unable or unwilling to follow study requirements, including signed consent or assent
Subject is hospitalized in the intensive care unit
Subject does not meet institutional MRI safety screening requirements
Subject has undergone primary tumor resection prior to arrival at St. Jude
Subjects who require sedation for WB MRI will be excluded if they have: * An acute cardiopulmonary process including, but not limited to, croup, reactive airways disease, pneumonia, clinical or radiological evidence of pericardial effusion or other cardiopulmonary disease * Vomiting within 24 hours of the MRI or substantial nausea that may preclude sedation as determined by the anesthesiologist or certified registered nurse anesthetist

PRIMARY OBJECTIVES:

I. To estimate the proportion of pediatric sarcoma patients, whose bone/bone marrow and soft-tissue metastasis status are correctly staged by whole body diffusion weighted MRI (whole brain [WB] diffusion weighted imaging [DWI]) at the time of diagnosis by comparing it to clinical stage.

II. To determine the correlation between changes in primary pediatric sarcoma 18F-fluorodeoxyglucose positron emission tomography (FDG PET) maximum standardized uptake values (SUVmax) and average DWI apparent diffusion coefficient (ADC) values from baseline (pre-treatment) to just prior to local control.

SECONDARY OBJECTIVES:

I. To estimate the sensitivity, specificity, accuracy, and negative and positive predictive values of WB DWI, PET-computed tomography (CT) and PET-CT + bone scan for detecting sites of metastatic tumor in pediatric sarcomas using biopsy or clinical follow-up (including imaging studies and clinical information) as the reference standards.

II. To compare the ability of WB MRI, PET-CT and PET-CT + bone scan to detect all sites of metastases in pediatric sarcoma patients using biopsy and clinical judgment as the reference standards.

III. To examine the associations of DWI ADC values of primary tumors at diagnosis and treatment protocol driven time points during therapy with tumor histology, tumor grade, Response Evaluation Criteria in Solid Tumors (RECIST) response, % tumor necrosis, FDG SUVmax and patient outcome.

IV. To compare whole body DWI to conventional T1 weighted (T1W) and short tau inversion recovery (STIR) whole body MRI for the detection of nodal, bone/bone marrow, soft-tissue or lung metastases among pediatric bone and soft-tissue sarcoma patients using biopsy and clinical judgment as the reference standards.

V. To investigate the value of a variety of quantitative parameters obtained from software analysis of the primary tumor, such as: histogram kurtosis, range, peak, shifts in peak, or tumor heterogeneity.

OUTLINE:

Patients undergo whole body DW-MRI and primary tumor DW-MRI at baseline and at specific treatment protocol imaging time points.

After completion of study, patients are followed up periodically.

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Diffusion Weighted Magnetic Resonance in Imaging Younger Patients with Newly Diagnosed Bone or Soft Tissue Sarcomas

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