Radiation-Free Whole Body MR Imaging for Childhood Cancer
Recruiting in Palo Alto (17 mi)
Overseen byHeike Daldrup-Link
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Heike E Daldrup-Link
Disqualifiers: Metal implants, Sedation, Hemosiderosis, others
No Placebo Group
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.
12345Is 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.
678910How 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.
1341112Eligibility 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.
+2 more
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
+3 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: WB-DW-MR scanExperimental Treatment4 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford University Cancer InstituteStanford, CA
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Who Is Running the Clinical Trial?
Heike E Daldrup-LinkLead Sponsor
References
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]Whole-body magnetic resonance imaging (MRI) has been investigated by multiple authors as a radiation-free alternative to positron emission tomography computed tomography (PET-CT) in children with lymphoma.
The Role of Whole-Body MRI in Pediatric Musculoskeletal Oncology: Current Concepts and Clinical Applications. [2021]Whole-body magnetic resonance imaging (WB-MRI) has gained importance in the field of musculoskeletal oncology over the last decades, consisting in a one-stop imaging method that allows a wide coverage assessment of both bone and soft tissue involvement. WB-MRI is valuable for diagnosis, staging, and follow-up in many oncologic diseases and is especially advantageous for the pediatric population since it avoids redundant examinations and exposure to ionizing radiation in patients who often undergo long-term surveillance. Its clinical application has been studied in many pediatric neoplasms, such as cancer predisposition syndromes, Langerhans cell histiocytosis, lymphoma, sarcomas, and neuroblastoma. The addition of diffusion-weighted sequences allows functional evaluation of neoplastic lesions, which is helpful in the assessment of viable tumor and response to treatment after neoadjuvant or adjuvant therapy. WB-MRI is an excellent alternative to fluorodeoxyglucose-positron emission tomography/computed tomography in oncologic children, with comparable accuracy and the convenience of being radiation-free, fast to perform, and available at a similar cost. The development of new techniques and protocols makes WB-MRI increasingly faster, safer, and more accessible, and it is important for referring physicians and radiologists to recognize the role of this imaging method in pediatric oncology. LEVEL OF EVIDENCE: 4 TECHNICAL EFFICACY STAGE: 2.
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]Imaging tests are essential for staging of children with cancer. However, CT and radiotracer-based imaging procedures are associated with substantial exposure to ionising radiation and risk of secondary cancer development later in life. Our aim was to create a highly effective, clinically feasible, ionising radiation-free staging method based on whole-body diffusion-weighted MRI and the iron supplement ferumoxytol, used off-label as a contrast agent.
Whole-body MRI in pediatric patients with cancer. [2018]Cancer is the leading cause of natural death in the pediatric populations of developed countries, yet cure rates are greater than 70% when a cancer is diagnosed in its early stages. Recent advances in magnetic resonance imaging methods have markedly improved diagnostic and therapeutic approaches, while avoiding the risks of ionizing radiation that are associated with most conventional radiological methods, such as computed tomography and positron emission tomography/computed tomography. The advent of whole-body magnetic resonance imaging in association with the development of metabolic- and function-based techniques has led to the use of whole-body magnetic resonance imaging for the screening, diagnosis, staging, response assessment, and post-therapeutic follow-up of children with solid sporadic tumours or those with related genetic syndromes. Here, the advantages, techniques, indications, and limitations of whole-body magnetic resonance imaging in the management of pediatric oncology patients are presented.
Whole-body magnetic resonance imaging in pediatric oncology - recommendations by the Oncology Task Force of the ESPR. [2021]The purpose of this recommendation of the Oncology Task Force of the European Society of Paediatric Radiology (ESPR) is to indicate reasonable applications of whole-body MRI in children with cancer and to address useful protocols to optimize workflow and diagnostic performance. Whole-body MRI as a radiation-free modality has been increasingly performed over the last two decades, and newer applications, as in screening of children with germ-line mutation cancer-related gene defects, are now widely accepted. We aim to provide a comprehensive outline of the diagnostic value for use in daily practice. Based on the results of our task force session in 2018 and the revision in 2019 during the ESPR meeting, we summarized our group's experiences in whole-body MRI. The lack of large evidence by clinical studies is challenging when focusing on a balanced view regarding the impact of whole-body MRI in pediatric oncology. Therefore, the final version of this recommendation was supported by the members of Oncology Task Force.
Current and potential imaging applications of ferumoxytol for magnetic resonance imaging. [2022]Contrast-enhanced magnetic resonance imaging is a commonly used diagnostic tool. Compared with standard gadolinium-based contrast agents, ferumoxytol (Feraheme, AMAG Pharmaceuticals, Waltham, MA), used as an alternative contrast medium, is feasible in patients with impaired renal function. Other attractive imaging features of i.v. ferumoxytol include a prolonged blood pool phase and delayed intracellular uptake. With its unique pharmacologic, metabolic, and imaging properties, ferumoxytol may play a crucial role in future magnetic resonance imaging of the central nervous system, various organs outside the central nervous system, and the cardiovascular system. Preclinical and clinical studies have demonstrated the overall safety and effectiveness of this novel contrast agent, with rarely occurring anaphylactoid reactions. The purpose of this review is to describe the general and organ-specific properties of ferumoxytol, as well as the advantages and potential pitfalls associated with its use in magnetic resonance imaging. To more fully demonstrate the applications of ferumoxytol throughout the body, an imaging atlas was created and is available online as supplementary material.
Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. [2023]Background Ferumoxytol is approved for use in the treatment of iron deficiency anemia, but it can serve as an alternative to gadolinium-based contrast agents. On the basis of postmarketing surveillance data, the Food and Drug Administration issued a black box warning regarding the risks of rare but serious acute hypersensitivity reactions during fast high-dose injection (510 mg iron in 17 seconds) for therapeutic use. Whereas single-center safety data for diagnostic use have been positive, multicenter data are lacking. Purpose To report multicenter safety data for off-label diagnostic ferumoxytol use. Materials and Methods The multicenter ferumoxytol MRI registry was established as an open-label nonrandomized surveillance databank without industry involvement. Each center monitored all ferumoxytol administrations, classified adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (grade 1-5), and assessed the relationship of AEs to ferumoxytol administration. AEs related to or possibly related to ferumoxytol injection were considered adverse reactions. The core laboratory adjudicated the AEs and classified them with the American College of Radiology (ACR) classification. Analysis of variance was used to compare vital signs. Results Between January 2003 and October 2018, 3215 patients (median age, 58 years; range, 1 day to 96 years; 1897 male patients) received 4240 ferumoxytol injections for MRI. Ferumoxytol dose ranged from 1 to 11 mg per kilogram of body weight (≤510 mg iron; rate ≤45 mg iron/sec). There were no systematic changes in vital signs after ferumoxytol administration (P > .05). No severe, life-threatening, or fatal AEs occurred. Eighty-three (1.9%) of 4240 AEs were related or possibly related to ferumoxytol infusions (75 mild [1.8%], eight moderate [0.2%]). Thirty-one AEs were classified as allergiclike reactions using ACR criteria but were consistent with minor infusion reactions observed with parenteral iron. Conclusion Diagnostic ferumoxytol use was well tolerated, associated with no serious adverse events, and implicated in few adverse reactions. Registry results indicate a positive safety profile for ferumoxytol use in MRI. © RSNA, 2019 Online supplemental material is available for this article.
Safety of ferumoxytol in children undergoing cardiac MRI under general anaesthesia. [2018]Ferumoxytol, an "off-label" contrast agent, allows for better cardiac MRI quality as compared with gadolinium-based contrast agents. However, hypotension has been reported with the use of ferumoxytol for indications other than cardiac MRI. The purpose of our investigation was to evaluate the safety of ferumoxytol in children undergoing general anaesthesia for cardiac MRI.
What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent. [2023]Despite the label change and the FDA's boxed warning added to the Feraheme (ferumoxytol) label in March 2015, radiologists have shown increasing interest in using ferumoxytol as an MR imaging contrast agent as a supplement or alternative to gadolinium. The goals of this study were to provide information regarding ferumoxytol safety as an imaging agent in a single center and to assess how the Feraheme label change may affect this potential, currently off-label indication.
Safety of Off-Label Use of Ferumoxtyol as a Contrast Agent for MRI: A Systematic Review and Meta-Analysis of Adverse Events. [2021]Ferumoxytol has been studied as an alternative to gadolinium-based MRI contrast agents, but regulatory body warnings currently limit its use.
How to Provide Gadolinium-Free PET/MR Cancer Staging of Children and Young Adults in Less than 1 h: the Stanford Approach. [2019]To provide clinically useful gadolinium-free whole-body cancer staging of children and young adults with integrated positron emission tomography/magnetic resonance (PET/MR) imaging in less than 1 h.
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]To describe our preliminary experience with simultaneous whole body (18)F-fluorodeoxyglucose ((18)F-FDG) positron emission tomography and magnetic resonance imaging (PET-MRI) in the evaluation of pediatric oncology patients.