Pilot Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
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.
|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 ]
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542879
|United States, California|
|Stanford University Cancer Institute||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Christopher Klenk 650-798-9096 email@example.com|
|Principal Investigator: Heike Daldrup-Link, MD|
|Principal Investigator:||Heike Daldrup-Link||Stanford University|