Suspended

Whole-Body MRI in the Evaluation of Pediatric Malignancies

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What is being tested

Data Collection

Who is being recruted

Burkitt Lymphoma+27

+ DNA Virus Infections

+ Hemic and Lymphatic Diseases

Until 21 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: October 2004
See protocol details

Summary

Principal SponsorAmerican College of Radiology Imaging Network
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2004

Actual date on which the first participant was enrolled.

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
NCT00072488NCT00228761
Principal SponsorAmerican College of Radiology Imaging Network
Last updated: January 27, 2026
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Burkitt LymphomaDNA Virus InfectionsHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroblastomaSarcomaTumor Virus InfectionsVirus DiseasesHistiocytosisHistiocytic Disorders, MalignantLymphoma, B-CellNeuroectodermal TumorsNeoplasms, Connective and Soft TissueNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialEpstein-Barr Virus InfectionsDendritic Cell Sarcoma, Interdigitating

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 Center

San Francisco, United StatesOpen UCSF Helen Diller Family Comprehensive Cancer Center in Google Maps
Suspended

Children's Hospital Center for Cancer and Blood Disorders

Aurora, United States
Suspended

Nemours Children's Clinic

Jacksonville, United States
Suspended

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, United States
Suspended21 Study Centers