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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01542879
Recruitment Status : Recruiting
First Posted : March 2, 2012
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Heike E Daldrup-Link, Stanford University

February 24, 2012
March 2, 2012
April 18, 2018
February 2012
June 2019   (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 ]
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Complete list of historical versions of study NCT01542879 on Archive Site
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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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Procedure: WB-DW-MR scan
    Other Name: Whole Body Diffusion Weighted MR scan
  • Procedure: 18F-FDG PET scan
    Other Name: Fludeoxyglucose PET scan
  • Drug: Ferumoxytol
    Other Name: feraheme
Experimental: WB-DW-MR scan
simultaneous WB-DW-MR scan and 18F FDG PET scan
  • Procedure: WB-DW-MR scan
  • Procedure: 18F-FDG PET scan
  • Drug: Ferumoxytol
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 Identifier (NCT Number) in Medline.
July 2019
June 2019   (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.
Sexes Eligible for Study: All
up to 40 Years   (Child, Adult)
United States
IRB-20221 ( Other Identifier: Stanford IRB )
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Heike E Daldrup-Link, Stanford University
Heike E Daldrup-Link
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Principal Investigator: Heike Daldrup-Link Stanford University
Stanford University
April 2018

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