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

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 3 4 11 12}

Research Team

Heike Daldrup-Link

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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]

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]

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]

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]

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 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 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]

References

1. Germany 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Role of Whole-Body MRI in Pediatric Musculoskeletal Oncology: Current Concepts and Clinical Applications. [2021]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Whole-body MRI in pediatric patients with cancer. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging in pediatric oncology - recommendations by the Oncology Task Force of the ESPR. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Current and potential imaging applications of ferumoxytol for magnetic resonance imaging. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety of ferumoxytol in children undergoing cardiac MRI under general anaesthesia. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent. [2023]

10. United States 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. [2021]

11. United States 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. [2019]

12. United States 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. [2020]