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

Primary Purpose

Lymphoma, Neuroblastoma, Sarcoma

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
computed tomography
magnetic resonance imaging
positron emission tomography
Sponsored by
American College of Radiology Imaging Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphoma focused on measuring 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

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Children's Hospital Center for Cancer and Blood Disorders
  • Nemours Children's Clinic
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
  • Children's Memorial Hospital - Chicago
  • Riley's Children Cancer Center at Riley Hospital for Children
  • Holden Comprehensive Cancer Center at University of Iowa
  • Massachusetts General Hospital
  • Mallinckrodt Institute of Radiology at Washington University Medical Center
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Memorial Sloan-Kettering Cancer Center
  • Children's Hospital of Philadelphia
  • Hasbro Children's Hospital
  • Hollings Cancer Center at Medical University of South Carolina
  • St. Jude Children's Research Hospital
  • Vanderbilt-Ingram Cancer Center
  • Children's & Women's Hospital of British Columbia
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Hospital for Sick Children

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 4, 2003
Last Updated
June 5, 2010
Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00072488
Brief Title
Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
Official Title
Whole-Body MRI in the Evaluation of Pediatric Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2005 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Neuroblastoma, Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn J. Siegel, MD
Organizational Affiliation
Mallinckrodt Institute of Radiology at Washington University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Children's Hospital Center for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207-8482
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Riley's Children Cancer Center at Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mallinckrodt Institute of Radiology at Washington University Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Children's & Women's Hospital of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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