Pilot Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
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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 10-15 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. |
- 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 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age of less than 30 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| Contact: Jennifer Vancil | 650-703-0705 | jvancil@stanford.edu |
| 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 | |
| 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: | March 26, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on June 17, 2013