Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 2016 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 11, 2016
Last verified: July 2016

February 24, 2012
July 11, 2016
February 2012
October 2017   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT01542879 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
Development of Radiation Free Whole Body MR Imaging Technique for Staging of 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 imaging 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 newer imaging tests referred to as whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The advantage of the new imaging test is that it is associated with no or significantly reduced radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole body MR and PET/MR will be compared with that of the conventional, standard imaging studies for tumor detecting.

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. Recently, integrated whole body PET/MRI technologies have been proposed as a compromise between radiation-free WB-DW MRI (which does not provide information about tumor metabolism) and PET/CT, which is associated with high radiation exposure.

Pediatric patients with a newly diagnosed malignant lymphoma, malignant sarcoma or other solid tumor, who are scheduled to undergo clinical imaging for tumor staging, will also undergo WB-DW-MR and integrated 18F-FDG PET/MR as a staging procedure prior to, during and after treatment. Following intravenous injection of ferumoxytol (Feraheme) and/or 18F-fluoro-deoxy-glucose (FDG), WB-DW-MR scans and integrated 18F-FDG PET/MR scans will be obtained simultaneously on a 3T PET/MR system with an acquisition time of 60-90 minutes. 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, 18F-FDG PET/MR studies and 18F-FDG PET or PET/CT scans. The presence or absence of tumor lesions will be confirmed by histopathology or clinical and imaging follow-up over at least one year as the standard of reference.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cancer
Device: WB-DW-MR scan
Experimental: WB-DW-MR scan
Intervention: Device: WB-DW-MR scan
Klenk C, Gawande R, Uslu L, Khurana A, Qiu D, Quon A, Donig J, Rosenberg J, Luna-Fineman S, Moseley M, Daldrup-Link HE. Ionising radiation-free whole-body MRI versus (18)F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre study. Lancet Oncol. 2014 Mar;15(3):275-85. doi: 10.1016/S1470-2045(14)70021-X. Epub 2014 Feb 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
November 2017
October 2017   (final data collection date for primary outcome measure)

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.
Both
up to 40 Years   (Child, Adult)
No
United States
 
NCT01542879
PEDSVAR0017, SU-02242012-9149
Yes
Not Provided
Not Provided
Heike E Daldrup-Link, Stanford University
Heike E Daldrup-Link
Not Provided
Principal Investigator: Heike Daldrup-Link Stanford University
Stanford University
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP