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

This study is currently recruiting participants.
Verified February 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01542879
First received: February 24, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


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: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WB-DW-MR scan Device: WB-DW-MR scan

  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
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
Stanford University
Investigators
Principal Investigator: Heike Daldrup-Link Stanford University
  More Information

No publications provided

Responsible Party: 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: February 5, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 23, 2014