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


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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.

Sponsors and Collaborators: American College of Radiology Imaging Network
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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

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
Richard A. Barth, MD  650-725-2548 

Delaware
      Alfred I. duPont Hospital for Children, Wilmington,  Delaware,  19104,  United States; Recruiting
James S. Meyer, MD  302-651-4686 

Florida
      Miami Children's Hospital, Miami,  Florida,  33155,  United States; Recruiting
L. Santiago Medina, MD, MPH  305-663-8440 

      University of Miami Sylvester Comprehensive Cancer Center, Miami,  Florida,  33136,  United States; Recruiting
Marco Amendola, MD  305-585-5057    mamendol@med.miami.edu 

Georgia
      AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta,  Georgia,  30322,  United States; Recruiting
J. Brad Wyly, MD  404-785-6407 

Indiana
      Riley Children Cancer Center at Riley Hospital for Children, Indianapolis,  Indiana,  46202-5200,  United States; Recruiting
Kimberly E. Applegate, MD, MS  317-274-2951 

Massachusetts
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States; Recruiting
Diego Jaramillo, MD  617-724-4207    djaramillo@partners.org 

Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
Joshi Aparna, MD  313-745-0094 

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0229,  United States; Recruiting
Barry Shulkin, MD  734-736-5081 

Missouri
      Mallinckrodt Institute of Radiology at Washington University Medical Center, St. Louis,  Missouri,  63110,  United States; Recruiting
Marilyn J. Siegel, MD  314-362-2927 

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Sara J. Abramson, MD, FACR  212-639-2184    abramsos@mskcc.org 

Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104-4399,  United States; Recruiting
Martin Charron, MD  215-590-2570    charron@email.chop.edu 

Tennessee
      St. Jude Children's Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Fredric Hoffer, MD, FAAP, FSIR  901-495-2507    fred.hoffer@stjude.org 

      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2675,  United States; Recruiting
Marta Hernanz-Schulman, MD  615-322-3288    marta.schulman@mcmail.vanderbilt.edu 

Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84132,  United States; Recruiting
Keith White, MD  801-581-7553 

Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States; Recruiting
Marguerite (Meg) T. Parisi, MD, MSEd  206-987-2135 

Canada, British Columbia
      British Columbia Children's Hospital, Vancouver,  British Columbia,  V6H 3V4,  Canada; Recruiting
Helen Nadel, MD  604-875-3034    hnadel@cw.bc.ca 

Canada, Ontario
      Hospital for Sick Children, Toronto,  Ontario,  M5G 1X8,  Canada; Recruiting
Stephen Miller, MD  416-813-5171 

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000339811; ACRIN-6660; NCT00072488
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

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Page Updated: September 6, 2005
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