75 Participants Needed

Radiation-Free Whole Body MR Imaging for Childhood Cancer

LB
Overseen ByLucia Barrato
Age: < 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Heike E Daldrup-Link
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, there are restrictions on using other investigational agents, especially for patients with iron overload.

Is ferumoxytol safe for use in MRI scans?

Ferumoxytol, used as a contrast agent in MRI scans, has been shown to be generally safe with few mild to moderate adverse reactions, such as minor infusion reactions. Serious adverse events are rare, and it is considered a safe alternative to gadolinium-based agents, especially for patients with kidney issues.12345

How is the Radiation-Free Whole Body MR Imaging treatment for childhood cancer different from other treatments?

This treatment is unique because it uses whole-body MRI combined with ferumoxytol, an iron supplement, as a contrast agent to avoid ionizing radiation, unlike traditional methods like CT or PET-CT scans that expose patients to radiation.678910

What data supports the effectiveness of the treatment 18-F-FDG PET/MR scan, Feraheme, ferumoxytol, 18-F-FDG PET scan, Fluorodeoxyglucose F 18, FDG-PET, Ferumoxytol, Feraheme, WB-DW-MR scan, Feraheme for childhood cancer?

Whole-body MRI, which is part of this treatment, is effective for diagnosing and monitoring cancer in children without using harmful radiation, making it a safer alternative to traditional methods like PET-CT scans. It has been shown to have comparable accuracy for staging and assessing treatment response in pediatric cancers.6781112

Who Is on the Research Team?

HD

Heike Daldrup-Link

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with a type of cancer that is not in the brain.
I have had or will have a PET scan for cancer staging.
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.
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Exclusion Criteria

I will not receive Ferumoxytol due to iron overload.
I have a condition related to iron overload in my body.
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
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Evaluation

Participants undergo whole body MR and PET/MR imaging to assess the extent and spread of the disease using new and standard imaging techniques

1-2 weeks
1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging, with results compared to standard imaging studies

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • 18-F-FDG PET/MR scan
  • 18-F-FDG PET scan
  • Ferumoxytol
  • WB-DW-MR scan
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: WB-DW-MR scanExperimental Treatment4 Interventions

18-F-FDG PET/MR scan is already approved in United States for the following indications:

🇺🇸
Approved in United States as Feraheme for:

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Who Is Running the Clinical Trial?

Heike E Daldrup-Link

Lead Sponsor

Trials
2
Recruited
110+

Published Research Related to This Trial

Whole-body MRI demonstrated a high sensitivity of 95.8% for staging pediatric lymphoma, making it a promising radiation-free alternative to PET-CT.
However, the specificity of whole-body MRI was relatively low at 21.8%, indicating that while it is good at detecting the disease, it may also produce a higher number of false positives.
Diagnostic accuracy of whole-body magnetic resonance imaging versus positron emission tomography-computed tomography for the staging of pediatric lymphoma: a systematic review and meta-analysis.Bhalla, D., Jana, M., Kandasamy, D.[2023]
Whole-body magnetic resonance imaging (WB-MRI) is a valuable, radiation-free imaging method for diagnosing and monitoring various pediatric cancers, allowing comprehensive assessment of both bone and soft tissue involvement.
WB-MRI provides comparable accuracy to traditional imaging methods like PET/CT while being faster and safer, making it particularly beneficial for children who require long-term surveillance for oncologic diseases.
The Role of Whole-Body MRI in Pediatric Musculoskeletal Oncology: Current Concepts and Clinical Applications.Guimarães, JB., da Cruz, IAN., Ahlawat, S., et al.[2021]
A new imaging method using ferumoxytol-enhanced whole-body diffusion-weighted MRI was developed, which eliminates exposure to ionizing radiation, unlike traditional (18)F-FDG PET/CT scans that expose patients to an average of 12.5 mSv of radiation.
This MRI method demonstrated comparable sensitivity (90.8%) and specificity (99.5%) to (18)F-FDG PET/CT for detecting malignant lesions, with very good agreement in tumor staging results, suggesting it could be a safer alternative for cancer staging in children and young adults.
Ionising radiation-free whole-body MRI versus (18)F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre study.Klenk, C., Gawande, R., Uslu, L., et al.[2022]

Citations

Diagnostic accuracy of whole-body magnetic resonance imaging versus positron emission tomography-computed tomography for the staging of pediatric lymphoma: a systematic review and meta-analysis. [2023]
The Role of Whole-Body MRI in Pediatric Musculoskeletal Oncology: Current Concepts and Clinical Applications. [2021]
Ionising radiation-free whole-body MRI versus (18)F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre study. [2022]
Whole-body MRI in pediatric patients with cancer. [2018]
Whole-body magnetic resonance imaging in pediatric oncology - recommendations by the Oncology Task Force of the ESPR. [2021]
Current and potential imaging applications of ferumoxytol for magnetic resonance imaging. [2022]
Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. [2023]
Safety of ferumoxytol in children undergoing cardiac MRI under general anaesthesia. [2018]
What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety of Off-Label Use of Ferumoxtyol as a Contrast Agent for MRI: A Systematic Review and Meta-Analysis of Adverse Events. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
How to Provide Gadolinium-Free PET/MR Cancer Staging of Children and Young Adults in Less than 1 h: the Stanford Approach. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Simultaneous whole body (18)F-fluorodeoxyglucose positron emission tomography magnetic resonance imaging for evaluation of pediatric cancer: Preliminary experience and comparison with (18)F-fluorodeoxyglucose positron emission tomography computed tomography. [2020]
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