Suspended

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

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What is being tested

computed tomography

+ magnetic resonance imaging
+ positron emission tomography
Procedure
Who is being recruted

Lymphoma

+ Neuroblastoma
+ Sarcoma
Until 21 Years
How is the trial designed

Diagnostic Study

Interventional
Study Start: October 2004

Summary

Principal SponsorAmerican College of Radiology Imaging Network
Last updated: June 8, 2010
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitleWhole-Body MRI in the Evaluation of Pediatric Malignancies 
Principal SponsorAmerican College of Radiology Imaging Network
Last updated: June 8, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
226 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lymphoma
Neuroblastoma
Sarcoma
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 21 locations
Suspended
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesSee the location
Suspended
Children's Hospital Center for Cancer and Blood DisordersAurora, United States
Suspended
Nemours Children's ClinicJacksonville, United States
Suspended
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, United States

Suspended21 Study Centers