MRF + IVIM MRI for Brain Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byLan Lu, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Case Comprehensive Cancer Center
Disqualifiers: Pregnancy, Metal implants, Claustrophobia, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study.
The primary objectives of this study are:
* To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage.
* To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on MRI imaging and does not mention medication restrictions.
What data supports the effectiveness of the treatment MRF + IVIM MRI for brain cancer?
Research shows that Magnetic Resonance Fingerprinting (MRF) can quickly and accurately map brain tumor characteristics, helping to distinguish between different types of brain tumors. This suggests that MRF, when used with IVIM MRI, could be effective in assessing and monitoring brain cancer.
12345Is Magnetic Resonance Fingerprinting (MRF) safe for use in humans?
Magnetic Resonance Fingerprinting (MRF) is a new MRI technique that has been used in various clinical applications, including brain and prostate imaging, without specific safety concerns reported in the available research. It is generally considered safe as it is a type of MRI, which is a non-invasive imaging method commonly used in medical practice.
24678How is the MRF + IVIM MRI treatment for brain cancer different from other treatments?
The MRF + IVIM MRI treatment is unique because it combines Magnetic Resonance Fingerprinting (MRF) and Intravoxel Incoherent Motion (IVIM) MRI to provide detailed, quantitative imaging of brain tumors, which can help differentiate between types of gliomas and assess tumor perfusion, potentially aiding in personalized treatment planning.
1591011Eligibility Criteria
This trial is for individuals who have had radiation therapy and are diagnosed with either recurrent brain tumors or radiation necrosis. It's also open to healthy people without brain diseases. Participants should not have a history of stroke, cognitive impairments, be able to consent, and have a life expectancy over 6 months.Inclusion Criteria
My tumor has come back or I have tissue damage from radiation.
I can take care of myself and perform daily activities.
I may have cancer spread beyond the brain and have had treatments, which will be reviewed.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
MRI Scan
Participants undergo a one-time MRI scan using MRF and IVIM techniques to differentiate between tumor recurrence and radiation necrosis
30-45 minutes
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the MRI scan
4 weeks
Participant Groups
The study tests an MRI technique called Magnetic Resonance Fingerprinting (MRF) combined with IVIM MRI without contrast. The goal is to get high-quality images quickly to distinguish between brains affected by tumor recurrence and those with tissue death due to radiation.
3Treatment groups
Experimental Treatment
Group I: Participants with Tumor RecurrenceExperimental Treatment1 Intervention
The MRI scans (MRF and IVIM) will be performed on participants with newly developed recurrent prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings
Group II: Participants with Radiation NecrosisExperimental Treatment1 Intervention
The MRI scans (MRF and IVIM) will be performed on participants with newly developed necrosis prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings
Group III: Healthy Volunteer ParticipantsExperimental Treatment1 Intervention
Healthy volunteers will be recruited to evaluate the capability of MRF in conjunction with intravoxel incoherent motion (IVIM) MRI and serve as healthy control data to compare with the participant data.
MRF in conjunction with IVIM MRI is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as MRF with IVIM MRI for:
- Diagnostic imaging for brain tumors
- Differentiation of tumor recurrence and radiation necrosis
🇪🇺 Approved in European Union as MRF with IVIM MRI for:
- Diagnostic imaging for brain tumors
- Differentiation of tumor recurrence and radiation necrosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic Taussig Cancer CenterCleveland, OH
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterCleveland, OH
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Who Is Running the Clinical Trial?
Case Comprehensive Cancer CenterLead Sponsor
The Cleveland ClinicCollaborator
References
Initial assessment of 3D magnetic resonance fingerprinting (MRF) towards quantitative brain imaging for radiation therapy. [2020]Magnetic resonance fingerprinting (MRF) provides quantitative T1/T2 maps, enabling applications in clinical radiotherapy such as large-scale, multi-center clinical trials for longitudinal assessment of therapy response. We evaluated the feasibility of a quantitative three-dimensional-MRF (3D-MRF) towards its radiotherapy applications of primary brain tumors.
Tailored magnetic resonance fingerprinting of post-operative pediatric brain tumor patients. [2023]Label="PURPOSE" NlmCategory="OBJECTIVE">Brain and spinal cord tumors are the second most common cancer in children and account for one out of four cancers diagnosed. However, the long acquisition times associated with acquiring both data types prohibit using quantitative MR (qMR) in pediatric imaging protocols. This study aims to demonstrate the tailored magnetic resonance fingerprinting's (TMRF) ability to simultaneously provide quantitative maps (T1, T2) and multi-contrast qualitative images (T1 weighted, T1 FLAIR, T2 weighted) rapidly in pediatric brain tumor patients.
Magnetic Resonance Fingerprinting to Characterize Childhood and Young Adult Brain Tumors. [2020]Magnetic resonance fingerprinting (MRF) allows rapid, simultaneous mapping of T1 and T2 relaxation times and may be an important diagnostic tool to measure tissue characteristics in pediatric brain tumors. We examined children and young adults with primary brain tumors to determine whether MRF can discriminate tumor from normal-appearing white matter and distinguish tumor grade.
Magnetic resonance fingerprinting: an overview. [2021]Magnetic resonance fingerprinting (MRF) is an evolving quantitative MRI framework consisting of unique data acquisition, processing, visualization, and interpretation steps. MRF is capable of simultaneously producing multiple high-resolution property maps including T1, T2, M0, ADC, and T2* measurements. While a relatively new technology, MRF has undergone rapid development for a variety of clinical applications from brain tumor characterization and epilepsy imaging to characterization of prostate cancer, cardiac imaging, among others. This paper will provide a brief overview of current state of MRF technology including highlights of technical and clinical advances. We will conclude with a brief discussion of the challenges that need to be overcome to establish MRF as a quantitative imaging biomarker.
MR Fingerprinting-A Radiogenomic Marker for Diffuse Gliomas. [2022](1) Background: Advanced MR imaging (MRI) of brain tumors is mainly based on qualitative contrast images. MR Fingerprinting (MRF) offers a novel approach. The purpose of this study was to use MRF-derived T1 and T2 relaxation maps to differentiate diffuse gliomas according to isocitrate dehydrogenase (IDH) mutation. (2) Methods: Twenty-four patients with histologically verified diffuse gliomas (14 IDH-mutant, four 1p/19q-codeleted, 10 IDH-wildtype) were enrolled. MRF T1 and T2 relaxation times were compared to apparent diffusion coefficient (ADC), relative cerebral blood volume (rCBV) within solid tumor, peritumoral edema, and normal-appearing white matter (NAWM), using contrast-enhanced MRI, diffusion-, perfusion-, and susceptibility-weighted imaging. For perfusion imaging, a T2* weighted perfusion sequence with leakage correction was used. Correlations of MRF T1 and T2 times with two established conventional sequences for T1 and T2 mapping were assessed (a fast double inversion recovery-based MR sequence ('MP2RAGE') for T1 quantification and a multi-contrast spin echo-based sequence for T2 quantification). (3) Results: MRF T1 and T2 relaxation times were significantly higher in the IDH-mutant than in IDH-wildtype gliomas within the solid part of the tumor (p = 0.024 for MRF T1, p = 0.041 for MRF T2). MRF T1 and T2 relaxation times were significantly higher in the IDH-wildtype than in IDH-mutant gliomas within peritumoral edema less than or equal to 1cm adjacent to the tumor (p = 0.038 for MRF T1 mean, p = 0.010 for MRF T2 mean). In the solid part of the tumor, there was a high correlation between MRF and conventionally measured T1 and T2 values (r = 0.913, p < 0.001 for T1, r = 0.775, p < 0.001 for T2), as well as between MRF and ADC values (r = 0.813, p < 0.001 for T2, r = 0.697, p < 0.001 for T1). The correlation was weak between the MRF and rCBV values (r = -0.374, p = 0.005 for T2, r = -0.181, p = 0.181 for T1). (4) Conclusions: MRF enables fast, single-sequence based, multi-parametric, quantitative tissue characterization of diffuse gliomas and may have the potential to differentiate IDH-mutant from IDH-wildtype gliomas.
Magnetic Resonance Fingerprinting-An Overview. [2020]Magnetic Resonance Fingerprinting (MRF) is a new approach to quantitative magnetic resonance imaging that allows simultaneous measurement of multiple tissue properties in a single, time-efficient acquisition. The ability to reproducibly and quantitatively measure tissue properties could enable more objective tissue diagnosis, comparisons of scans acquired at different locations and time points, longitudinal follow-up of individual patients and development of imaging biomarkers. This review provides a general overview of MRF technology, current preclinical and clinical applications and potential future directions. MRF has been initially evaluated in brain, prostate, liver, cardiac, musculoskeletal imaging, and measurement of perfusion and microvascular properties through MR vascular fingerprinting.
Toward magnetic resonance fingerprinting for low-field MR-guided radiation therapy. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">The acquisition of multiparametric quantitative magnetic resonance imaging (qMRI) is becoming increasingly important for functional characterization of cancer prior to- and throughout the course of radiation therapy. The feasibility of a qMRI method known as magnetic resonance fingerprinting (MRF) for rapid T1 and T2 mapping was assessed on a low-field MR-linac system.
Feasibility of MR fingerprinting using a high-performance 0.55 T MRI system. [2022]MR fingerprinting (MRF) is a versatile method for rapid multi-parametric quantification. The application of MRF for lower MRI field could enable multi-contrast imaging and improve exam efficiency on these systems. The purpose of this work is to demonstrate the feasibility of 3D whole-brain T1 and T2 mapping using MR fingerprinting on a contemporary 0.55 T MRI system.
Glioma grading and IDH1 mutational status: assessment by intravoxel incoherent motion MRI. [2020]To assess the diagnostic performance of intravoxel incoherent motion (IVIM) magnetic resonance imaging (MRI) in differentiating high-grade gliomas (HGGs) from low-grade gliomas (LGGs), and predicting the isocitrate dehydrogenase 1 (IDH1) mutational status.
Intravoxel Incoherent Motion Metrics as Potential Biomarkers for Survival in Glioblastoma. [2018]Intravoxel incoherent motion (IVIM) is an MRI technique with potential applications in measuring brain tumor perfusion, but its clinical impact remains to be determined. We assessed the usefulness of IVIM-metrics in predicting survival in newly diagnosed glioblastoma.
Accurate intravoxel incoherent motion parameter estimation using Bayesian fitting and reduced number of low b-values. [2021]Intravoxel incoherent motion (IVIM) magnetic resonance imaging is a potential noninvasive technique for the diagnosis of brain tumors. However, perfusion-related parameter mapping is a persistent problem. The purpose of this paper is to investigate the IVIM parameter mapping of brain tumors using Bayesian fitting and low b-values.