Whole-Body MRI in the Evaluation of Pediatric Malignancies

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bradley Wyly, Emory University
ClinicalTrials.gov Identifier:
NCT00228761
First received: September 27, 2005
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

Eligible patients will have a cancer that is known to spread to other areas of the body (metastasize). This study will look at the best way to see if and where the cancer has spread (metastatic disease). The standard tests (conventional imaging tests) that are used to determine the extent and spread of these diseases may include magnetic resonance imaging (MRI), computed tomography (CT), bone scanning, gallium scanning, and/or metaiodobenzylguanidine (MIBG) scanning. The standard tests that are required will depend on the specific disease. The main purpose of this research study is to see if a new imaging test, called whole-body fast MRI, can detect disease as accurately as the standard tests. Whole-body fast MRI is a diagnostic test that uses a large magnet to take pictures of the body with rapid imaging times. Up to now, it has not been used routinely in the evaluation of children with cancer. The results of whole-body fast MRI will be compared with that of conventional imaging for detecting distant metastases.


Condition Intervention
Metastatic Cancer
Procedure: PET, MRI, CT scans

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Whole-Body MRI in the Evaluation of Pediatric Malignancies

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • compare the results of the experimental tests with the results provided by the standard diagnostic work-up [ Time Frame: 1 year after close of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: June 2004
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: PET, MRI, CT scans
    scans
Detailed Description:

Eligible patients will have a cancer that is known to spread to other areas of the body (metastasize). This study will look at the best way to see if and where the cancer has spread (metastatic disease). The standard tests (conventional imaging tests) that are used to determine the extent and spread of these diseases may include magnetic resonance imaging (MRI), computed tomography (CT), bone scanning, gallium scanning, and/or metaiodobenzylguanidine (MIBG) scanning. The standard tests that are required will depend on the specific disease. The main purpose of this research study is to see if a new imaging test, called whole-body fast MRI, can detect disease as accurately as the standard tests. Whole-body fast MRI is a diagnostic test that uses a large magnet to take pictures of the body with rapid imaging times. Up to now, it has not been used routinely in the evaluation of children with cancer. The results of whole-body fast MRI will be compared with that of conventional imaging for detecting distant metastases.

In addition to studying whole-body fast MRI; the study doctors would also like to look at a second imaging study called positron emissions tomography (PET). A PET scan is a specialized imaging test that uses radiation to locate areas of disease. The PET scan portion of this study is completely optional.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

a cancer that is known to spread to other areas of the body (metastasize) -

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228761

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Brad Wyly, MD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Bradley Wyly, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00228761     History of Changes
Other Study ID Numbers: IRB00024898, 336-2004
Study First Received: September 27, 2005
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014