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

November 20, 2024 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 (Estimated)

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

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Cancer Institute
        • Contact:
        • 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

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
Procedure: WB-DW-MR scan
WB-DW-MR scans will be obtained on a 3T PET-MR system
Other Names:
  • Whole Body Diffusion Weighted MR scan
Procedure: 18-F-FDG PET scan
Other Names:
  • Fludeoxyglucose PET scan
Drug: Ferumoxytol
Other Names:
  • feraheme
Procedure: 18-F-FDG PET/MR scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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
To determine sensitivity and specificity for lesion detection on whole-body scans, the body is divided into 10 anatomical regions, and qualified professionals evaluate each region for the presence or absence of tumor lesions. These results are then compared to the gold standard (established through biopsy and follow-up imaging), allowing for the calculation of true positives, false positives, true negatives, and false negatives for each region. Sensitivity and specificity can then be calculated using these values, providing a measure of the scan's accuracy in detecting lesions across different body areas.
The outcome will be measured after image acquisition

Secondary Outcome Measures

Outcome Measure
Measure Description
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
To determine sensitivity and specificity for lesion detection on whole-body scans, the body is divided into 10 anatomical regions, and qualified professionals evaluate each region for the presence or absence of tumor lesions. These results are then compared to the gold standard (established through biopsy or follow-up imaging), allowing for the calculation of true positives, false positives, true negatives, and false negatives for each region. Sensitivity and specificity can then be calculated using these values, providing a measure of the scan's accuracy in detecting lesions across different body areas.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heike E Daldrup-Link

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

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 (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimated)

March 2, 2012

Study Record Updates

Last Update Posted (Actual)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

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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