NCT01542879

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.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Heike E Daldrup-Link · Academic / Other
• Sex: All
• Age: 6 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
PROCEDURE	WB-DW-MR scan	WB-DW-MR scans will be obtained on a 3T PET-MR system
PROCEDURE	18-F-FDG PET scan
DRUG	Ferumoxytol
PROCEDURE	18-F-FDG PET/MR scan

Timeline

• Start date: 2012-02-01
• Primary completion: 2025-10-01
• Completion: 2026-12-01
• First posted: 2012-03-02
• Last updated: 2024-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study