Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
Recruitment status was Active, not recruiting
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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: | Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Whole-Body MRI in the Evaluation of Pediatric Malignancies |
| Estimated Enrollment: | 226 |
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
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 |
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
Show 21 Study Locations| Principal Investigator: | Marilyn J. Siegel, MD | Mallinckrodt Institute of Radiology at Washington University Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00072488 History of Changes |
| Other Study ID Numbers: | CDR0000339811, ACRIN-6660 |
| Study First Received: | November 4, 2003 |
| Last Updated: | June 5, 2010 |
| Health Authority: | United States: Federal Government |
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:
|
Lymphoma Neuroblastoma Lymphoma, Non-Hodgkin Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Connective and Soft Tissue |
ClinicalTrials.gov processed this record on May 23, 2013