NCT00072488Unknown不适用
Whole-Body MRI in the Evaluation of Pediatric Malignancies
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 226
- 试验地点
- 21
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •21 and under
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No active cardiac pacemakers
- •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
- •Prior biopsy or surgery allowed provided no more than 2 months has passed since the procedure
排除标准
- 未提供
研究者
研究点 (21)
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