- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01542879
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
April 3, 2023 updated by: Heike E Daldrup-Link
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
75
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lucia Barrato
- Phone Number: 415 307 1990
- Email: lbaratto@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University Cancer Institute
-
Contact:
- Lucia Barrato
- Phone Number: 415-307-1990
- Email: 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
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WB-DW-MR scan
simultaneous WB-DW-MR scan and 18-F FDG PET scan
|
WB-DW-MR scans will be obtained on a 3T PET-MR system
Other Names:
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
The outcome will be measured after image acquisition
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heike Daldrup-Link, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Theruvath AJ, Siedek F, Yerneni K, Muehe AM, Spunt SL, Pribnow A, Moseley M, Lu Y, Zhao Q, Gulaka P, Chaudhari A, Daldrup-Link HE. Validation of Deep Learning-based Augmentation for Reduced 18F-FDG Dose for PET/MRI in Children and Young Adults with Lymphoma. Radiol Artif Intell. 2021 Oct 6;3(6):e200232. doi: 10.1148/ryai.2021200232. eCollection 2021 Nov.
- Theruvath AJ, Siedek F, Muehe AM, Garcia-Diaz J, Kirchner J, Martin O, Link MP, Spunt S, Pribnow A, Rosenberg J, Herrmann K, Gatidis S, Schafer JF, Moseley M, Umutlu L, Daldrup-Link HE. Therapy Response Assessment of Pediatric Tumors with Whole-Body Diffusion-weighted MRI and FDG PET/MRI. Radiology. 2020 Jul;296(1):143-151. doi: 10.1148/radiol.2020192508. Epub 2020 May 5.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Anticipated)
October 1, 2025
Study Completion (Anticipated)
December 1, 2026
Study Registration Dates
First Submitted
February 24, 2012
First Submitted That Met QC Criteria
March 1, 2012
First Posted (Estimate)
March 2, 2012
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
April 3, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-20221 (Other Identifier: Stanford IRB)
- PEDSVAR0017 (Other Identifier: OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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