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Clinical Trial: Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
This study is currently recruiting patients.
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: Diagnostic trial to compare the effectiveness of whole-body MRI with that of standard imaging procedures in detecting distant metastases in patients who have solid tumors or lymphoma.
| Condition | Treatment or Intervention |
|---|---|
| Ewing's family of tumors childhood Hodgkin's lymphoma childhood non-Hodgkin's lymphoma childhood rhabdomyosarcoma Neuroblastoma | Procedure: computed tomography Procedure: diagnostic test Procedure: magnetic resonance imaging Procedure: tomography, emission computed |
MedlinePlus related topics: Bone Cancer; Hodgkin's Disease; Lymphoma; Neuroblastoma; Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Diagnostic
Official Title: Diagnostic Study of Whole-Body MRI and Conventional Imaging For Detecting Distant Metastases in Pediatric Patients With Solid Tumor Malignancies or Lymphoma
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
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 14 days of any diagnostic or operative procedure
- Whole body MRI and positron emission tomograpy (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
- Not specified
Location and Contact Information
California
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5105, United States; Recruiting
Delaware
Alfred I. duPont Hospital for Children, Wilmington, Delaware, 19104, United States; Recruiting
Florida
Miami Children's Hospital, Miami, Florida, 33155, United States; Recruiting
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, 33136, United States; Recruiting
Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, 30322, United States; Recruiting
Indiana
Riley Children Cancer Center at Riley Hospital for Children, Indianapolis, Indiana, 46202-5200, United States; Recruiting
Massachusetts
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States; Recruiting
Michigan
Children's Hospital of Michigan, Detroit, Michigan, 48201, United States; Recruiting
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0229, United States; Recruiting
Missouri
Mallinckrodt Institute of Radiology at Washington University Medical Center, St. Louis, Missouri, 63110, United States; Recruiting
New York
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104-4399, United States; Recruiting
Tennessee
St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States; Recruiting
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-2675, United States; Recruiting
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84132, United States; Recruiting
Washington
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, 98105, United States; Recruiting
Canada, British Columbia
British Columbia Children's Hospital, Vancouver, British Columbia, V6H 3V4, Canada; Recruiting
Canada, Ontario
Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada; Recruiting
Marilyn J. Siegel, MD, Principal Investigator, Mallinckrodt Institute of Radiology at Washington University Medical Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2005
Last Updated: March 10, 2005
Record first received: November 4, 2003
ClinicalTrials.gov Identifier: NCT00072488
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Administration for Children and Families
- After an Affair: How Marital Therapy Heals the Wounds (American Association for Marriage and Family Therapy)

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