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

Phase 1

Recruiting

• Conditions: Cancer
• Interventions: Procedure: WB-DW-MR scan; Procedure: 18-F-FDG PET scan; Drug: Ferumoxytol; Procedure: 18-F-FDG PET/MR scan

• Registration Number: NCT01542879
• Lead Sponsor: Heike E Daldrup-Link

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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WB-DW-MR scan	18-F-FDG PET/MR scan	simultaneous WB-DW-MR scan and 18-F FDG PET scan
WB-DW-MR scan	WB-DW-MR scan	simultaneous WB-DW-MR scan and 18-F FDG PET scan
WB-DW-MR scan	18-F-FDG PET scan	simultaneous WB-DW-MR scan and 18-F FDG PET scan
WB-DW-MR scan	Ferumoxytol	simultaneous WB-DW-MR scan and 18-F FDG PET scan

Primary Outcome Measures

Name	Time	Method
Comparison of sensitivity, specificity and accuracy of WB-DW-MR scans to 18-F FDG PET scans.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Stanford University Cancer Institute; 🇺🇸 Stanford, California, United States