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Radiation-Free Whole Body MR Imaging for Childhood Cancer

Phase 1 & 2
Recruiting
Led By Heike Daldrup-Link
Research Sponsored by Heike E Daldrup-Link
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of a solid extra-cranial tumor like malignant lymphoma or malignant sarcoma
Very young children who need sedation or anesthesia will be excluded from the study
Must not have
Restrictions regarding use of other Investigational Agents: Pt with iron-overload will not receive Ferumoxytol
Need of sedation or claustrophobia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing if a new whole-body imaging technique can detect the extent and spread of disease in children as accurately as standard tests, but with less radiation exposure.

Who is the study for?
This trial is for children with solid tumors outside the brain, like lymphoma or sarcoma. They must be scheduled for or have completed a PET scan and can't be too young to require sedation. Consent from parents/guardians and assent from minors are needed.
What is being tested?
The study tests new whole body MR imaging techniques using ferumoxytol contrast against standard CT and PET/CT scans to see if they're as good or better at finding how far cancer has spread, but with less radiation exposure.
What are the potential side effects?
Potential side effects may include allergic reactions to the ferumoxytol contrast agent used in MR imaging, discomfort during the scan process, and anxiety related to undergoing multiple diagnostic tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a type of cancer that is not in the brain.
Select...
My child does not require sedation or anesthesia for medical procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I will not receive Ferumoxytol due to iron overload.
Select...
I need sedation or have claustrophobia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: WB-DW-MR scanExperimental Treatment4 Interventions
simultaneous WB-DW-MR scan and 18-F FDG PET scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferumoxytol
FDA approved

Find a Location

Who is running the clinical trial?

Heike E Daldrup-LinkLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
Heike Daldrup-LinkPrincipal InvestigatorStanford University

Media Library

18-F-FDG PET/MR scan Clinical Trial Eligibility Overview. Trial Name: NCT01542879 — Phase 1 & 2
Cancer Research Study Groups: WB-DW-MR scan
Cancer Clinical Trial 2023: 18-F-FDG PET/MR scan Highlights & Side Effects. Trial Name: NCT01542879 — Phase 1 & 2
18-F-FDG PET/MR scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT01542879 — Phase 1 & 2
~5 spots leftby Oct 2025
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