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

Part of paid clinical trials in Stanford, California.

Sponsor
Heike E Daldrup-Link
Study ID
NCT01542879
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
6 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 29, 2012
Status verified
Nov 2024
Primary completion
Oct 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: WB-DW-MR scan
    simultaneous WB-DW-MR scan and 18-F FDG PET scan

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Cancer InstituteStanfordCalifornia94305
Lucia Barrato
415-307-1990
Heike Daldrup-Link, MD (PRINCIPAL_INVESTIGATOR)
Andrew Quon (SUB_INVESTIGATOR)
Neyssa Marina (SUB_INVESTIGATOR)
Florette Kimberley Hazard (SUB_INVESTIGATOR)
Dita Gratzinger (SUB_INVESTIGATOR)
Anne Muehe (PRINCIPAL_INVESTIGATOR)

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