Clinical trial NCT00072488: Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
Official title: Whole-Body MRI in the Evaluation of Pediatric Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Neuroblastoma
Sarcoma
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-11-06
Enrollment: 226
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: Children's Hospital Center for Cancer and Blood Disorders
state: Colorado
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
city: Atlanta
country: United States
facility: AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
state: Georgia
city: Chicago
country: United States
facility: Children's Memorial Hospital - Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Riley's Children Cancer Center at Riley Hospital for Children
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: St. Louis
country: United States
facility: Mallinckrodt Institute of Radiology at Washington University Medical Center
state: Missouri
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Vancouver
country: Canada
facility: Children's & Women's Hospital of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital at Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Mallinckrodt Institute of Radiology at Washington University Medical Center
name: Marilyn J. Siegel, MD
role: PRINCIPAL_INVESTIGATOR
References: