Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
NCT ID: NCT00072488
Last Updated: 2010-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
226 participants
INTERVENTIONAL
2004-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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DIAGNOSTIC
NONE
Interventions
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computed tomography
magnetic resonance imaging
positron emission tomography
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
American College of Radiology Imaging Network
NETWORK
Principal Investigators
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Marilyn J. Siegel, MD
Role: PRINCIPAL_INVESTIGATOR
Mallinckrodt Institute of Radiology at Washington University Medical Center
Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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ACRIN-6660
Identifier Type: -
Identifier Source: secondary_id
CDR0000339811
Identifier Type: -
Identifier Source: org_study_id
NCT00228761
Identifier Type: -
Identifier Source: nct_alias
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