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

Sponsor:	American College of Radiology Imaging Network
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072488

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: 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.

Condition	Intervention
Lymphoma Neuroblastoma Sarcoma	Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: positron emission tomography

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Whole-Body MRI in the Evaluation of Pediatric Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma MRI Scans Neuroblastoma Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	226
Study Start Date:	October 2004
Estimated Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072488

Show 21 Study Locations

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Marilyn J. Siegel, MD

Mallinckrodt Institute of Radiology at Washington University Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000339811, ACRIN-6660
Study First Received:	November 4, 2003
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00072488 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Neuroectodermal Tumors, Primitive
Immune System Diseases
Neoplasms, Nerve Tissue
Neuroblastoma
Neoplasms, Connective and Soft Tissue
Neuroectodermal Tumors
Lymphatic Diseases

Neoplasms
Neoplasms, Germ Cell and Embryonal
Sarcoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms, Neuroepithelial
Lymphoma
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010