Radiation-Free Whole Body MR Imaging for Childhood Cancer

Overseen By Lucia Barrato

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Heike E Daldrup-Link

Disqualifiers: Metal implants, Sedation, Hemosiderosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if new whole-body MR imaging techniques can detect the spread of solid tumors in children as well as or better than standard imaging tests like CT or PET scans. The focus is on reducing radiation exposure while accurately identifying the extent of the disease. The trial includes testing a new MR contrast agent called ferumoxytol. Children diagnosed with solid tumors, such as lymphoma or sarcoma, who are scheduled for PET scans are suitable candidates. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group. Participants have the opportunity to contribute to groundbreaking advancements in pediatric cancer imaging.

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.

What prior data suggests that this whole body imaging technique is safe for children with solid tumors?

Research has shown that whole-body diffusion-weighted MRI (WB-DW-MR) is a promising method for detecting cancer spread in children. This technique uses a special contrast agent called ferumoxytol and, unlike traditional CT or PET scans, does not expose patients to harmful radiation.

Studies have found that WB-DW-MR is generally well-tolerated and avoids radiation risks, making it safer for children. Although any new technique can have potential risks, no major problems have been reported with this method. This suggests that WB-DW-MR is a safe alternative for imaging in children with cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a radiation-free imaging technique for diagnosing and monitoring childhood cancer. Unlike conventional methods like CT scans and traditional PET scans, which expose patients to radiation, the whole-body diffusion-weighted MRI (WB-DW-MR) scan combined with an 18-F-FDG PET scan offers a potentially safer alternative. This approach could reduce the long-term risks associated with radiation exposure in children, making it a promising option for young patients. Additionally, the simultaneous scanning method could improve the accuracy and efficiency of cancer detection and monitoring.

What evidence suggests that this imaging technique is effective for detecting the spread of childhood cancer?

Research has shown that whole-body diffusion-weighted MRI (WB-DW-MR) scans can diagnose and monitor cancer in children without harmful radiation. In this trial, participants will undergo a simultaneous WB-DW-MR scan and 18-F FDG PET scan. Studies have found that WB-DW-MR and traditional PET scans agree well on tumor response to treatment. This imaging method provides clear pictures and takes less time than standard scans. WB-DW-MR is particularly useful for conditions like lymphoma and serves as a good alternative to tests that use more radiation. Overall, this technique offers a safer way to check if cancer has spread in children. ^{2 6 7 8 9}

Who Is on the Research Team?

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.

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

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?

Group I: WB-DW-MR scan Experimental Treatment 4 Interventions

simultaneous WB-DW-MR scan and 18-F FDG PET scan

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

Approved in United States as Feraheme for:

• Iron deficiency anemia in adult patients with chronic kidney disease

Who Is Running the Clinical Trial?

Heike E Daldrup-Link

Lead Sponsor

Trials

2

Recruited

110+

Published Research Related to This Trial

Ferumoxytol is a promising alternative to standard gadolinium-based contrast agents for MRI, especially in patients with impaired kidney function, due to its unique properties like prolonged blood pool phase and delayed intracellular uptake.

Clinical studies indicate that ferumoxytol is generally safe and effective, with very few cases of anaphylactoid reactions, making it a viable option for imaging various organs and the central nervous system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and potential imaging applications of ferumoxytol for magnetic resonance imaging. Toth, GB., Varallyay, CG., Horvath, A., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Whole-body MRI is a radiation-free imaging technique that has become increasingly accepted for use in children with cancer, particularly for screening those with genetic mutations related to cancer.

The recommendations from the European Society of Paediatric Radiology emphasize the need for optimized protocols to enhance the diagnostic performance of whole-body MRI, despite the current lack of extensive clinical evidence supporting its widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging in pediatric oncology - recommendations by the Oncology Task Force of the ESPR. Schäfer, JF., Granata, C., von Kalle, T., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 95 children undergoing general anesthesia for cardiac MRI, the use of ferumoxytol as a contrast agent did not lead to a higher incidence of hypotension compared to gadolinium-based agents, indicating its safety in this context.

Ferumoxytol was associated with significantly shorter imaging and anesthesia durations, suggesting it may improve the efficiency of cardiac MRI procedures without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ferumoxytol in children undergoing cardiac MRI under general anaesthesia. Wise-Faberowski, L., Velasquez, N., Chan, F., et al.[2018]

In a multicenter study involving 3215 patients who received 4240 ferumoxytol injections for MRI, the use of ferumoxytol was well tolerated with no severe or life-threatening adverse events reported.

Only 1.9% of patients experienced adverse reactions related to ferumoxytol, mostly mild, indicating a positive safety profile for its off-label diagnostic use as an alternative to gadolinium-based contrast agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. Nguyen, KL., Yoshida, T., Kathuria-Prakash, N., et al.[2023]

In a study of 671 MR imaging procedures using ferumoxytol in 331 patients, no serious or life-threatening adverse events were reported, indicating a strong safety profile for this contrast agent.

The overall rate of mild adverse events was 10.6%, with common issues including hypertension and nausea, suggesting that while some patients may experience side effects, serious complications are rare when proper precautions are taken.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent. Varallyay, CG., Toth, GB., Fu, R., et al.[2023]

In a systematic review of 39 studies involving 5411 ferumoxytol administrations, the overall adverse event rate for using ferumoxytol as an MRI contrast agent was found to be low at 2%, with no reported deaths and only rare severe reactions.

The majority of adverse events (88%) were mild, indicating that ferumoxytol may be a safe alternative to gadolinium-based contrast agents, although further research is needed, especially for patients with prior hypersensitivity reactions to gadolinium.

NCBI (Pubmed)

pubmed.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. Ahmad, F., Treanor, L., McGrath, TA., et al.[2021]

The streamlined ferumoxytol-enhanced PET/MR imaging protocol allowed for whole-body cancer staging in children and young adults in under 1 hour, significantly reducing scan times from 36 to 24 minutes while also minimizing radiation exposure compared to traditional PET/CT scans.

This method provided equal or superior tumor staging results in 17 out of 20 patients, demonstrating its efficacy, although it showed lower detection rates for small pulmonary nodules (less than 5 mm) compared to PET/CT.

NCBI (Pubmed)

pubmed.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. Muehe, AM., Theruvath, AJ., Lai, L., et al.[2019]

In a study involving 7 pediatric oncology patients, simultaneous whole body PET-MRI demonstrated excellent correlation with PET-CT for detecting both benign and malignant lesions, with a correlation coefficient of R = 0.93.

PET-MRI showed superior accuracy in identifying malignant lesions compared to the minimum apparent diffusion coefficient (ADCmin) measurements, indicating its potential as a valuable tool in the evaluation of pediatric cancer patients.

NCBI (Pubmed)

pubmed.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. Pugmire, BS., Guimaraes, AR., Lim, R., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 (MRI) has become a crucial tool in pediatric oncology, significantly improving the screening, diagnosis, and follow-up of children with solid tumors while avoiding the risks associated with ionizing radiation from traditional imaging methods.

The use of advanced metabolic and functional MRI techniques enhances the ability to assess tumor response and stage disease, contributing to better treatment outcomes for pediatric patients, especially when cancers are diagnosed early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body MRI in pediatric patients with cancer. Guimarães, MD., Noschang, J., Teixeira, SR., et al.[2018]

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