Pilot Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Heike E Daldrup-Link, Stanford University
ClinicalTrials.gov Identifier:
NCT01542879
First received: February 24, 2012
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body MRI technique and a new MR contrast agent (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG) scanning. The purpose of this study is to determine if a newer imaging test referred to as whole body MR can detect the extent and spread of the disease as accurately or even better as the standard tests. The advantage of the new imaging test is that it is not associated with any radiation exposure. The results of whole body MR will be compared with that of the conventional, standard imaging studies for detecting distant metastases.


Condition Intervention
Cancer
Device: WB-DW-MR scan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Development of Radiation Free Whole Body MR Imaging Technique for Staging of Children With Cancer.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • comparison of sensitivity, specificity and accuracy of WB-DW-MR scans to 18 F-FDG-PET scans. [ Time Frame: The outcome will be measured after image acquisition ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WB-DW-MR scan Device: WB-DW-MR scan

Detailed Description:

New developments in magnetic resonance (MR) imaging technology provide an alternative to radiographic staging techniques. Novel whole body (WB) diffusion weighted MR scans (WB-DW-MR) provide a very high tumor-to background contrast, similar to 18F-FDG PET scans. Therefore, this study was designed to compare the sensitivity of whole-body MR and 18F-FDG PET for detecting metastatic disease in children with malignant lymphomas and malignant sarcomas.

Pediatric patients with a newly diagnosed malignant lymphoma or malignant sarcoma, who are scheduled to undergo an 18F-FDG PET or PET/CT scan for tumor staging, will also undergo WB-DW-MR as an initial staging procedure prior to treatment. WB-DW-MR scans from head to toe will be obtained on a 3T MR system with an acquisition time of 30-60 minutes. Of note, the WB-DW-MR exam does not involve radiation exposure, anesthesia or any intravenous injection. Very young patients who would need an anesthesia or sedation for this study will be excluded in order to keep this initial research exam minimally invasive. Two experienced pediatric radiologists will determine the presence, location and size of primary tumors and metastases separately for the WB-DW-MR studies and 18F-FDG PET scans. The presence or absence of metastases will be confirmed by histopathology or clinical and imaging follow-up over at least one year as the standard of reference.

  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age of less than 40 years
  • diagnosis of a malignant lymphoma or sarcoma
  • scheduled for or completed a PET or PET/CT tumor staging procedure.

Exclusion Criteria:

  • MR-incompatible metal implants
  • need of sedation
  • claustrophobia.
  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: NCT01542879

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Christopher Klenk    650-798-9096    cklenk@stanford.edu   
Principal Investigator: Heike Daldrup-Link, MD         
Sponsors and Collaborators
Heike E Daldrup-Link
Investigators
Principal Investigator: Heike Daldrup-Link Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heike E Daldrup-Link, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01542879     History of Changes
Other Study ID Numbers: PEDSVAR0017, SU-02242012-9149
Study First Received: February 24, 2012
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 21, 2014