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Radiation-Free Imaging for Cancer Staging in Children

This study is looking at new ways to image children with cancer to see if their disease has spread, without using radiation. Researchers are comparing a new imaging technique called whole body diffusion-weighted MR (WB-DW-MR) scans and whole body PET/MR scans with standard imaging tests like 18-F-FDG PET scans. They also use a special contrast agent called Ferumoxytol. The goal is to see if these newer methods are as good as or better than current tests at finding cancer spread. You might be able to join if you are between 6 and 40 years old, have a solid tumor like lymphoma or sarcoma, and are scheduled for or have already had an 18F-FDG-PET or 18F-FDG-PET/CT scan. The study aims to enroll 75 participants, but the current status is unclear.

Study design
This interventional study plans to enroll 75 participants to compare different imaging techniques.
What's involved
You would undergo WB-DW-MR scans and 18-F-FDG PET scans, potentially with the drug Ferumoxytol.
Compensation
Not stated in the trial record.
Follow-up
The outcome will be measured after image acquisition.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01542879

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

Recruiting
PHASE1Ages 6–40InterventionalDiagnostic
Heike E Daldrup-Link
~75 participants
Updated 2024-11-25 on ClinicalTrials.gov
What's tested:WB-DW-MR scan18-F-FDG PET scanFerumoxytol18-F-FDG PET/MR scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of sensitivity, specificity and accuracy of WB-DW-MR scans to 18-F FDG PET scans.
Measured over The outcome will be measured after image acquisition

Conditions

Cancer

Explore related trials

LymphomaSarcomaSolid Neoplasm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Heike Daldrup-Link · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Lucia Barrato
[email protected]
415 307 1990
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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.