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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00072488
First received: November 4, 2003
Last updated: June 5, 2010
Last verified: October 2007
  Purpose

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 Intervention
Lymphoma
Neuroblastoma
Sarcoma
Procedure: computed tomography
Procedure: magnetic resonance imaging
Procedure: positron emission tomography

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Whole-Body MRI in the Evaluation of Pediatric Malignancies

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 226
Study Start Date: October 2004
Estimated Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072488

  Show 21 Study Locations
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Principal Investigator: Marilyn J. Siegel, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00072488     History of Changes
Other Study ID Numbers: CDR0000339811, ACRIN-6660
Study First Received: November 4, 2003
Last Updated: June 5, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Sarcoma
Neuroblastoma
Lymphoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014