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Whole-Body MRI in the Evaluation of Pediatric Malignancies

21 Years
Open (Enrolling)
Lymphoma, Neuroblastoma, Sarcoma

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Trial Information

Whole-Body MRI in the Evaluation of Pediatric Malignancies



- 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.


- 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

- 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.

Inclusion Criteria


- Confirmed diagnosis OR newly diagnosed mass strongly suspected to represent 1 of the

- 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

- 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

- 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



- 21 and under

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No active cardiac pacemakers


- 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)


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- Not specified


- Prior biopsy or surgery allowed provided no more than 2 months has passed since the

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Principal Investigator

Marilyn J. Siegel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mallinckrodt Institute of Radiology at Washington University Medical Center


United States: Federal Government

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • Neuroblastoma
  • Sarcoma
  • 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
  • Lymphoma
  • Neuroblastoma
  • Lymphoma, Non-Hodgkin
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Nemours Children's Clinic Jacksonville, Florida  32207
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Children's Hospital Center for Cancer and Blood Disorders Aurora, Colorado  80045
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta, Georgia  30322
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Riley's Children Cancer Center at Riley Hospital for Children Indianapolis, Indiana  46202-5225
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Mallinckrodt Institute of Radiology at Washington University Medical Center St. Louis, Missouri  63110
Hasbro Children's Hospital Providence, Rhode Island  02903