7T MRI Scan for Detecting Melanoma Brain Tumors
Recruiting in Palo Alto (17 mi)
Overseen ByLindsay Hwang
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Southern California
Must not be taking: Anxiolytics
Disqualifiers: Recent neurosurgery, Claustrophobia, Poor renal function, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial studies using a special MRI machine with a stronger magnet to take clearer pictures of the brain in patients whose melanoma has spread there. The goal is to see if this new MRI can find cancer better than the standard MRI.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. It seems you may continue with previous systemic therapy, immunotherapy, or checkpoint inhibitors, but it's best to confirm with the study team.
What data supports the effectiveness of the treatment 7T MRI for detecting melanoma brain tumors?
Research shows that 7T MRI provides high-resolution images and enhanced contrast, which can help in better visualizing brain tumors and planning treatments. It has been used effectively for imaging other brain conditions, like glioblastoma, and offers improved detail compared to lower strength MRIs.
12345Is 7T MRI safe for humans?
7T MRI is generally considered safe for humans, but it can cause side effects like dizziness, nausea, and feelings of motion. There are also safety concerns with metallic implants due to the strong magnetic field, and special care is needed to avoid heating and other risks.
45678How does the 7T MRI scan treatment for detecting melanoma brain tumors differ from other treatments?
The 7T MRI scan is unique because it uses an ultra-high magnetic field strength to provide highly detailed images of the brain, which can help in detecting melanoma brain tumors with greater precision compared to standard MRI scans. This advanced imaging technique offers improved spatial resolution and contrast, allowing for better visualization of brain structures and potential abnormalities.
23459Eligibility Criteria
This trial is for adults with melanoma that may have spread to the brain. Participants must be able to undergo MRI scans without distress, have a performance status indicating they can carry out daily activities, and agree to use contraception. It's not suitable for those with poor kidney function, recent neurosurgery or radiotherapy, uncontrolled illnesses, claustrophobia severe enough to prevent MRI scans, incompatible implants, or allergies to contrast agents used in MRIs.Inclusion Criteria
I am able to care for myself but may not be able to do active work.
I have melanoma with new brain metastases not yet treated.
Ability to understand and the willingness to sign a written informed consent
+5 more
Exclusion Criteria
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
I had brain surgery more than 30 days ago or have recovered from it.
Patients with MRI-incompatible pacemakers or MRI-incompatible implants
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2 weeks
Diagnostic
Patients undergo 7T MRI scan with and without contrast over 1-2 hours
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the diagnostic procedure
2 weeks
Participant Groups
The study is testing whether a high-resolution 7 Tesla (7T) MRI scan can detect brain metastases from melanoma more effectively than the standard 3 Tesla (3T) MRI scan. The goal is early detection of cancer spread which could lead to better treatment outcomes.
1Treatment groups
Experimental Treatment
Group I: Diagnostic (7T MRI)Experimental Treatment1 Intervention
Within 2 weeks of initial standard of care 3T MRI, patients undergo 7T MRI scan with and without contrast over 1-2 hours.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
USC / Norris Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
High-resolution FLAIR MRI at 7 Tesla for treatment planning in glioblastoma patients. [2019]Ultra-high field MRI is an emerging technique promising high-resolution images for radiotherapy planning. We compared a 7 Tesla FLAIR sequence with clinical FLAIR imaging at 3 Tesla in glioblastoma patients before radiotherapy. High-resolution 7 Tesla FLAIR imaging may enhance the depiction of organs at risk and possibly modify target volumes.
7 Tesla MR imaging: opportunities and challenges. [2022]The urge to increase magnetic field strength is driven by a number of potentially beneficial physical changes, possibly resulting in improved MR diagnostics. With the successful introduction of in-vivo ultra-high-field MR imaging, by means of 7 Tesla MRI, the focus of scientific research has been set on compiling different applications of brain and body imaging. This review presents an overview on the current status of 7 T MR imaging, investigating the opportunities as well as challenges associated with ultra-high-field MRI. Citation Format: • Umutlu L, Ladd ME, Forsting M et al. 7 Tesla MR Imaging: Opportunities and Challenges. Fortschr Röntgenstr 2014; 186: 121 - 129.
Clinical magnetic resonance imaging of brain tumors at ultrahigh field: a state-of-the-art review. [2018]With the advancement of the magnetic resonance (MR) technology, the whole-body ultrahigh field MR system operated from 7 to 9.4 T becomes feasible for the routine patient imaging in clinical settings. The associated potentials and challenges from the perspectives of technology, physics, and biology as well as clinical application of the ultrahigh field MR systems are different from those systems operated at 3 T, 1.5 T, or lower field strength. In this article, we will present our initial experiences of brain tumor imaging using the 7 and 8 T whole-body MR systems at the Ohio State University Medical Center and provide a brief overview pertinent to the ultrahigh field clinical MR systems.
Ultra-High-Field MR Neuroimaging. [2018]At ultra-high magnetic fields, such as 7T, MR imaging can noninvasively visualize the brain in unprecedented detail and through enhanced contrast mechanisms. The increased SNR and enhanced contrast available at 7T enable higher resolution anatomic and vascular imaging. Greater spectral separation improves detection and characterization of metabolites in spectroscopic imaging. Enhanced blood oxygen level-dependent contrast affords higher resolution functional MR imaging. Ultra-high-field MR imaging also facilitates imaging of nonproton nuclei such as sodium and phosphorus. These improved imaging methods may be applied to detect subtle anatomic, functional, and metabolic abnormalities associated with a wide range of neurologic disorders, including epilepsy, brain tumors, multiple sclerosis, Alzheimer disease, and psychiatric conditions. At 7T, however, physical and hardware limitations cause conventional MR imaging pulse sequences to generate artifacts, requiring specialized pulse sequences and new hardware solutions to maximize the high-field gain in signal and contrast. Practical considerations for ultra-high-field MR imaging include cost, siting, and patient experience.
Use of a Commercial 7-T MRI Scanner for Clinical Brain Imaging: Indications, Protocols, Challenges, and Solutions-A Single-Center Experience. [2023]The first commercially available 7-T MRI scanner (Magnetom Terra) was approved by the FDA in 2017 for clinical imaging of the brain and knee. After initial protocol development and sequence optimization efforts in volunteers, the 7-T system, in combination with an FDA-approved 1-channel transmit/32-channel receive array head coil, can now be routinely used for clinical brain MRI examinations. The ultrahigh field strength of 7-T MRI has the advantages of improved spatial resolution, increased SNR, and increased CNR but also introduces an array of new technical challenges. The purpose of this article is to describe an institutional experience with the use of the commercially available 7-T MRI scanner for routine clinical brain imaging. Specific clinical indications for which 7-T MRI may be useful for brain imaging include brain tumor evaluation with possible perfusion imaging and/or spectroscopy, radiotherapy planning; evaluation of multiple sclerosis and other demyelinating diseases, evaluation of Parkinson disease and guidance of deep brain stimulator placement, high-detail intracranial MRA and vessel wall imaging, evaluation of pituitary pathology, and evaluation of epilepsy. Detailed protocols, including sequence parameters, for these various indications are presented, and implementation challenges (including artifacts, safety, and side effects) and potential solutions are explored.
7T MR Safety. [2021]Magnetic resonance imaging and spectroscopy (MRI/MRS) at 7T represents an exciting advance in MR technology, with intriguing possibilities to enhance image spatial, spectral, and contrast resolution. To ensure the safe use of this technology while still harnessing its potential, clinical staff and researchers need to be cognizant of some safety concerns arising from the increased magnetic field strength and higher Larmor frequency. The higher static magnetic fields give rise to enhanced transient bioeffects and an increased risk of adverse incidents related to electrically conductive implants. Many technical challenges remain and the continuing rapid pace of development of 7T MRI/MRS is likely to present further challenges to ensuring safety of this technology in the years ahead. The recent regulatory clearance for clinical diagnostic imaging at 7T will likely increase the installed base of 7T systems, particularly in hospital environments with little prior ultrahigh-field MR experience. Informed risk/benefit analyses will be required, particularly where implant manufacturer-published 7T safety guidelines for implants are unavailable. On behalf of the International Society for Magnetic Resonance in Medicine, the aim of this article is to provide a reference document to assist institutions developing local institutional policies and procedures that are specific to the safe operation of 7T MRI/MRS. Details of current 7T technology and the physics underpinning its functionality are reviewed, with the aim of supporting efforts to expand the use of 7T MRI/MRS in both research and clinical environments. Current gaps in knowledge are also identified, where additional research and development are required. Level of Evidence 5 Technical Efficacy 2 J. MAGN. RESON. IMAGING 2021;53:333-346.
Safety for Human MR Scanners at 7T. [2022]After introduction of the first human 7 tesla (7T) system in 1999, 7T MR systems have been employed as one of the most advanced platforms for human MR research for more than 20 years. Currently, two 7T MR models are approved for clinical use in the U.S.A. The approval facilitated introduction of the 7T system, summing up to around 100 worldwide. The approval in Japan is much awaited. As a clinical MR scanner, the 7T MR system is drawing attention in terms of safety.Several large-sized studies on bioeffects have been reported for vertigo, dizziness, motion disturbances, nausea, and others. Such effects might also be found in MR workers and researchers. Frequency and severity of reported bioeffects will be presented and discussed, including their variances. The high resonance frequency and shorter RF wavelength of 7T increase the concern about the safety. Homogeneous RF pulse excitation is difficult even for the brain, and a multi-channel parallel transmit (pTx) system is considered mandatory. However, pTx may create a hot spot, which makes the estimation of specific absorption rate (SAR) to be difficult. The stronger magnetic field of 7T causes a large force of displacement and heating on metallic implants or devices, and the scan of patients with them should not be conducted at 7T. However, there are some opinions that such patients might be scanned even at 7T, if certain criteria are met. This article provides a brief review on the effect of the static magnetic field on humans (MR subjects, workers, and researchers) and neurons, in addition to scan sound, SAR, and metal implants and devices. Understanding and avoiding adverse effects will contribute to the reduction in safety risks and the prevention of incidents.
Safety Considerations of 7-T MRI in Clinical Practice. [2020]Although 7-T MRI has recently received approval for use in clinical patient care, there are distinct safety issues associated with this relatively high magnetic field. Forces on metallic implants and radiofrequency power deposition and heating are safety considerations at 7 T. Patient bioeffects such as vertigo, dizziness, false feelings of motion, nausea, nystagmus, magnetophosphenes, and electrogustatory effects are more common and potentially more pronounced at 7 T than at lower field strengths. Herein the authors review safety issues associated with 7-T MRI. The rationale for safety concerns at this field strength are discussed as well as potential approaches to mitigate risk to patients and health care professionals.
7-T MR--from research to clinical applications? [2021]Over 20,000 MR systems are currently installed worldwide and, although the majority operate at magnetic fields of 1.5 T and below (i.e. about 70%), experience with 3-T (in high-field clinical diagnostic imaging and research) and 7-T (research only) human MR scanners points to a future in functional and metabolic MR diagnostics. Complementary to previous studies, this review attempts to provide an overview of ultrahigh-field MR research with special emphasis on emerging clinical applications at 7 T. We provide a short summary of the technical development and the current status of installed MR systems. The advantages and challenges of ultrahigh-field MRI and MRS are discussed with special emphasis on radiofrequency inhomogeneity, relaxation times, signal-to-noise improvements, susceptibility effects, chemical shifts, specific absorption rate and other safety issues. In terms of applications, we focus on the topics most likely to gain significantly from 7-T MR, i.e. brain imaging and spectroscopy and musculoskeletal imaging, but also body imaging, which is particularly challenging. Examples are given to demonstrate the advantages of susceptibility-weighted imaging, time-of-flight MR angiography, high-resolution functional MRI, (1)H and (31)P MRSI in the human brain, sodium and functional imaging of cartilage and the first results (and artefacts) using an eight-channel body array, suggesting future areas of research that should be intensified in order to fully explore the potential of 7-T MR systems for use in clinical diagnosis.