LymphomaNCT00072488
Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
A study testing computed tomography, magnetic resonance imaging and positron emission tomography in people with Lymphoma and Neuroblastoma, run by American College of Radiology Imaging Network at 21 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Lymphoma, Neuroblastoma, Sarcoma
- What is being tested?
- computed tomography, magnetic resonance imaging and positron emission tomography
- Type of treatment
- Surgery or procedure
- How many people
- 226 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Oct 2004to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States17 sites
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, 30322
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, 46202-5225
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Nemours Children's Clinic
Jacksonville, Florida, 32207-8482
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Hasbro Children's Hospital
Providence, Rhode Island, 02903
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, 63110
Canada4 sites
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Whole-Body MRI in the Evaluation of Pediatric Malignancies
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.
Read the 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.
- Conditions
- Lymphoma, Neuroblastoma, Sarcoma
- Being tested
- computed tomography, magnetic resonance imaging, positron emission tomography
- 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
- Medical subject headings
- Lymphoma, Neuroblastoma, Sarcoma, Dendritic Cell Sarcoma, Interdigitating, Burkitt Lymphoma, Neuroectodermal Tumors, Primitive, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
magnetic resonance imagingProcedure or surgery
positron emission tomographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
- Study startOct 2004
- Primary completionDec 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American College of Radiology Imaging Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Marilyn J. Siegel, MD, Principal investigator, Mallinckrodt Institute of Radiology at Washington University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072488
- Sponsor's protocol ID
- CDR0000339811
- Other IDs
- ACRIN-6660
- Status last verified
- Oct 2007
- First submitted
- 4 Nov 2003
- Last updated
- 8 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body MRI in the Evaluation of Pediatric Malignancies
- ClinicalTrials.gov ID
- NCT00072488
- Acronym / sponsor ID
- CDR0000339811
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- American College of Radiology Imaging NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2004
- Primary completion
- Dec 2005 (estimated)
- First posted
- 6 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomography | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| positron emission tomography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn J. Siegel, MD principal investigator
Mallinckrodt Institute of Radiology at Washington University Medical Center
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography, magnetic resonance imaging and positron emission tomography in people with Lymphoma and Neuroblastoma, run by American College of Radiology Imaging Network at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2010.