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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

November 4, 2003
November 6, 2003
June 8, 2010
October 2004
December 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00072488 on Archive Site
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Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
Whole-Body MRI in the Evaluation of Pediatric Malignancies

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.



  • 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.

Not Applicable
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Lymphoma
  • Neuroblastoma
  • Sarcoma
  • Procedure: computed tomography
  • Procedure: magnetic resonance imaging
  • Procedure: positron emission tomography
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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December 2005   (Final data collection date for primary outcome measure)


  • 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



  • 21 and under

Performance status

  • Not specified

Life expectancy

  • Not specified


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  • 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)


Biologic therapy

  • Not specified


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Endocrine therapy

  • Not specified


  • Not specified


  • Prior biopsy or surgery allowed provided no more than 2 months has passed since the procedure
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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American College of Radiology Imaging Network
National Cancer Institute (NCI)
Principal Investigator: Marilyn J. Siegel, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP