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

Lymphoma Clinical Trial

Official title:

Whole-Body MRI in the Evaluation of Pediatric Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00072488
• Other study ID #: CDR0000339811
• Secondary ID: ACRIN-6660
• Status: Active, not recruiting
• Phase: N/A
• First received: November 4, 2003
• Last updated: June 5, 2010
• Start date: October 2004

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00228761

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 226
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma
• Neuroblastoma
• Sarcoma

Intervention

Procedure:
• computed tomography

• magnetic resonance imaging

• positron emission tomography

Locations

Country	Name	City	State
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	Children's & Women's Hospital of British Columbia	Vancouver	British Columbia
United States	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus	Atlanta	Georgia
United States	Children's Hospital Center for Cancer and Blood Disorders	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
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	Nemours Children's Clinic	Jacksonville	Florida
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
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	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Mallinckrodt Institute of Radiology at Washington University Medical Center	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,