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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.
 
ClinicalTrials.gov Identifier: NCT01542879
Recruitment Status : Recruiting
First Posted : March 2, 2012
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Heike E Daldrup-Link, Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Procedure: WB-DW-MR scan Procedure: 18-F-FDG PET scan Drug: Ferumoxytol Procedure: 18-F-FDG PET/MR scan Phase 1 Phase 2

Detailed Description:
Primary Objective: To compare the sensitivity, specificity and accuracy of WB-DW-MR scans (new technique) with 18F- FDG PET or 18F- FDG PET/CT or 18F- FDG PET/MR scans.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of Radiation Free Whole Body MR Imaging Technique for Staging of Children With Cancer.
Study Start Date : February 2012
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: WB-DW-MR scan
simultaneous WB-DW-MR scan and 18-F FDG PET scan
 Procedure: WB-DW-MR scan
WB-DW-MR scans will be obtained on a 3T PET-MR system
Other Name: Whole Body Diffusion Weighted MR scan

Procedure: 18-F-FDG PET scan
Other Name: Fludeoxyglucose PET scan

Drug: Ferumoxytol
Other Name: feraheme

Procedure: 18-F-FDG PET/MR scan


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Comparison of sensitivity, specificity and accuracy of Ferumoxytol-enhanced whole-body 18-F FDG PET/MR-scans versus standard clinical Gadolinium-enhanced whole-body 18-F FDG PET/MR-scans. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of a solid extra-cranial tumor like malignant lymphoma or malignant sarcoma and
  • Scheduled for or completed a 18F-FDG-PET or 18F-FDG-PET/CT tumor staging procedure.
  • There will be no restrictions on prior treatment.
  • Very young children who need sedation or anesthesia will be excluded from the study.
  • In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate.

Exclusion Criteria:

  • MR-incompatible metal implants,
  • need of sedation or claustrophobia.
  • Hemosiderosis/hemochromatosis (patients can still be included in 2nd branch without ferumoxytol)
  • There will be restrictions regarding use of other Investigational Agents: Pt with iron-overload will not receive Ferumoxytol
  • History of allergic reactions to similar compounds will be obtained and patients with a positive history of allergic reaction to iron compounds or other severe allergic reactions.will be excluded from the study.
  • Pregnant women and fetuses.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542879


Contacts
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Contact: Lucia Barrato 415 307 1990 lbaratto@stanford.edu

Locations
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United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Lucia Barrato    415-307-1990    lbaratto@stanford.edu   
Principal Investigator: Heike Daldrup-Link, MD         
Sub-Investigator: Andrew Quon         
Sub-Investigator: Neyssa Marina         
Sub-Investigator: Florette Kimberley Hazard         
Sub-Investigator: Dita Gratzinger         
Principal Investigator: Anne Muehe         
Sponsors and Collaborators
Heike E Daldrup-Link
Investigators
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Principal Investigator: Heike Daldrup-Link Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Heike E Daldrup-Link, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01542879    
Other Study ID Numbers: IRB-20221
IRB-20221 ( Other Identifier: Stanford IRB )
PEDSVAR0017 ( Other Identifier: OnCore )
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ferrosoferric Oxide
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
 Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions