MRF + IVIM MRI for Brain Cancer

Recruiting at 1 trial location

Overseen By Lan Lu, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Pregnancy, Metal implants, Claustrophobia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new MRI technique, Magnetic Resonance Fingerprinting (MRF), to quickly and accurately image the brain in just five minutes. The researchers aim to determine if MRF, combined with Intravoxel Incoherent Motion Magnetic Resonance Imaging (IVIM MRI), can distinguish between brains affected by radiation damage and those with returning tumors. This could improve diagnosis and treatment planning for individuals who have undergone radiation therapy for brain conditions or have newly diagnosed brain tumors. Suitable participants include those with recurrent brain tumors, untreated brain metastases or gliomas, radiation necrosis, or healthy individuals without brain diseases. Participants will undergo a single MRI scan without any additional tests. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future brain imaging techniques.

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 prior data suggests that this MRI technique is safe for brain imaging?

Research has shown that Magnetic Resonance Fingerprinting (MRF) and Intravoxel Incoherent Motion (IVIM) MRI are safe imaging methods. Studies have found that these techniques can help distinguish between tumor growth and radiation damage in the brain. Because these imaging methods do not involve drugs or surgery, they are generally considered low-risk for participants. As non-invasive procedures, meaning they don't enter the body, no reports of negative effects have emerged from these MRI methods. Participants can expect an experience similar to a standard MRI scan, which is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRF and IVIM MRI for brain cancer because these imaging techniques could offer a more precise and non-invasive way to assess and differentiate between types of brain abnormalities. Unlike traditional imaging methods, these advanced MRI techniques can provide detailed insights into tissue characteristics without requiring immediate surgical intervention. This could lead to earlier and more accurate diagnoses, potentially improving treatment planning and outcomes for patients with brain metastases, primary gliomas, radiation necrosis, and tumor recurrence. Additionally, having healthy volunteers as a control group helps validate the effectiveness and accuracy of these techniques, paving the way for their broader application in clinical settings.

What evidence suggests that MRF in conjunction with IVIM MRI is effective for differentiating between tumor recurrence and radiation necrosis?

This trial will evaluate the use of Magnetic Resonance Fingerprinting (MRF) with Intravoxel Incoherent Motion (IVIM) MRI in various participant groups, including those with brain metastases, primary gliomas, radiation necrosis, tumor recurrence, and healthy volunteers. Research has shown that MRF with IVIM MRI can help differentiate between a returning brain tumor and radiation-induced damage. These advanced imaging methods produce detailed pictures of brain tissues, crucial for accurate diagnosis. MRF, combined with IVIM, captures high-quality images quickly, in about 5 minutes, providing a clearer view of the brain's condition. IVIM adds extra information by analyzing water movement in tissues, aiding in distinguishing different types of brain damage. This method has shown promise in accurately identifying brain changes, which is important for determining the best treatment. ^{1 2 5 6 7}

Who Is on the Research Team?

Samuel T. Chao, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Lan Lu, PhD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MRF in conjunction with IVIM MRI

Trial Overview

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.

How Is the Trial Designed?

Group I: Participants with Tumor Recurrence Experimental Treatment 1 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 Necrosis Experimental Treatment 1 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: Participants with Primary Gliomas Experimental Treatment 1 Intervention

The MRI scans (MRF and IVIM) will be performed on participants with newly developed, untreated primary gliomas prior to any 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 IV: Participants with Brain Metastases Experimental Treatment 1 Intervention

The MRI scans (MRF and IVIM) will be performed on participants with newly developed, untreated brain metastases prior to any 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 V: Healthy Volunteer Participants Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

Magnetic resonance fingerprinting (MRF) has been shown to accurately map T1 and T2 values within 8% and 10% of gold standard measures, respectively, on a low-field MR-guided radiotherapy system, demonstrating its feasibility for cancer characterization.

MRF can produce reliable T1 and T2 maps in just 6 minutes, with a coefficient of variation of less than 5% over repeated scans, indicating its potential for efficient and reproducible quantitative MRI in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward magnetic resonance fingerprinting for low-field MR-guided radiation therapy. Mickevicius, NJ., Kim, JP., Zhao, J., et al.[2022]

Magnetic Resonance Fingerprinting (MRF) is a cutting-edge imaging technique that allows for the simultaneous and efficient measurement of multiple tissue properties, which could lead to more accurate and objective diagnoses.

MRF has shown promise in various applications, including brain, prostate, liver, and cardiac imaging, as well as in assessing microvascular properties, indicating its potential to enhance patient monitoring and the development of imaging biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Fingerprinting-An Overview. Panda, A., Mehta, BB., Coppo, S., et al.[2020]

The study successfully demonstrated the feasibility of using MR fingerprinting (MRF) for 3D whole-brain T1 and T2 mapping on a 0.55 T MRI system, achieving high spatial resolution and a quick acquisition time of 8.5 minutes.

T1 and T2 values obtained from MRF were highly correlated with standard measurements, showing strong accuracy and precision (less than 5%) even in the lower signal-to-noise ratio environment of 0.55 T.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of MR fingerprinting using a high-performance 0.55 T MRI system. Campbell-Washburn, AE., Jiang, Y., Körzdörfer, G., et al.[2022]

The optimized 3D magnetic resonance fingerprinting (MRF) technique provides accurate and reproducible T1 and T2 maps of brain tissue, demonstrating improved repeatability and robustness against motion artifacts compared to conventional MRI methods.

This technique shows promise for longitudinal assessment of treatment responses in brain tumors, making it suitable for large-scale clinical trials in radiotherapy settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial assessment of 3D magnetic resonance fingerprinting (MRF) towards quantitative brain imaging for radiation therapy. Lu, L., Chen, Y., Shen, C., et al.[2020]

Tailored magnetic resonance fingerprinting (TMRF) can rapidly provide quantitative maps (T1, T2) and qualitative images in pediatric brain tumor patients, potentially saving about 2 minutes in imaging time.

In a study of five pediatric patients, TMRF-derived T2 weighted images showed strong correlation with standard imaging methods, indicating its effectiveness in differentiating between healthy and pathological tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored magnetic resonance fingerprinting of post-operative pediatric brain tumor patients. Poojar, P., Qian, E., Jin, Z., et al.[2023]

Magnetic resonance fingerprinting (MRF) can quickly and effectively differentiate between tumor tissue and normal white matter in pediatric brain tumor patients, with a median scan time of just 11 minutes.

MRF successfully distinguishes between low-grade and high-grade tumors based on T1 and T2 relaxation times, indicating its potential as a valuable diagnostic tool for assessing tumor characteristics in children and young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Fingerprinting to Characterize Childhood and Young Adult Brain Tumors. de Blank, P., Badve, C., Gold, DR., et al.[2020]

Magnetic resonance fingerprinting (MRF) is a cutting-edge MRI technology that can simultaneously generate multiple high-resolution property maps, such as T1, T2, and ADC measurements, which are useful for various clinical applications including brain tumors and prostate cancer.

Despite its rapid development and potential, MRF still faces challenges that need to be addressed to fully establish it as a reliable quantitative imaging biomarker in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance fingerprinting: an overview. Tippareddy, C., Zhao, W., Sunshine, JL., et al.[2021]

MR Fingerprinting (MRF) can effectively differentiate between IDH-mutant and IDH-wildtype diffuse gliomas based on T1 and T2 relaxation times, with significant differences observed in the solid tumor regions of 24 patients studied.

The study found a strong correlation between MRF-derived relaxation times and conventional MRI measurements, suggesting that MRF provides a reliable and efficient method for characterizing brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR Fingerprinting-A Radiogenomic Marker for Diffuse Gliomas. Springer, E., Cardoso, PL., Strasser, B., et al.[2022]

In a study of 15 patients with newly diagnosed glioblastoma, the IVIM metrics of perfusion fraction (fCER) and pseudodiffusion coefficient (D*CER) were found to be strong predictors of 6-month survival, with specific cutoffs indicating high sensitivity and specificity.

The combination of fCER and treatment status provided a 100% accuracy rate in predicting survival, highlighting the potential of IVIM metrics as valuable biomarkers in assessing prognosis for glioblastoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravoxel Incoherent Motion Metrics as Potential Biomarkers for Survival in Glioblastoma. Puig, J., Sánchez-González, J., Blasco, G., et al.[2018]

Intravoxel incoherent motion (IVIM) MRI can effectively differentiate between high-grade gliomas (HGGs) and low-grade gliomas (LGGs), showing significant differences in diffusion metrics such as lower ADC and higher perfusion fraction in HGGs, with an area under the ROC curve (AUC) of 0.937.

IVIM MRI also predicts IDH1 mutational status, with LGGs having a higher ADC in mutated tumors compared to wild-type, and HGGs showing distinct diffusion characteristics based on IDH1 status, indicating its potential as a non-invasive diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glioma grading and IDH1 mutational status: assessment by intravoxel incoherent motion MRI. Wang, X., Chen, XZ., Shi, L., et al.[2020]

The study demonstrates that Bayesian shrinkage prior (BSP) fitting provides more accurate IVIM parameter mapping for brain tumors compared to least squares (LSQ), requiring fewer low b-values and resulting in lower variability and higher reproducibility.

IVIM parameters effectively differentiate brain tumors from normal tissue, with significant differences observed in the perfusion fraction (F) and diffusion (D) values, indicating the potential of this technique for noninvasive tumor diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accurate intravoxel incoherent motion parameter estimation using Bayesian fitting and reduced number of low b-values. Ye, C., Xu, D., Qin, Y., et al.[2021]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06101069

Development of MRF for Characterization of Brain Tumors ...

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.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11719598/

Research Progress on Glioma Microenvironment and ...

This review examines the current applications of advanced multi-parameter quantitative MRI in glioma research and explores the prospects for future development.

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ejrnm.springeropen.com

ejrnm.springeropen.com/articles/10.1186/s43055-025-01478-1

The value of intra-voxel incoherent motion, susceptibility ...

The current study aims to assess the role of new multi-parametric MRI techniques as intra-voxel incoherent motion, T2* perfusion, T1 permeability and ...

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researchgate.net

researchgate.net/figure/Intravoxel-incoherent-motion-IVIM-diffusion-weighted-imaging-in-glioblastoma-MRI-of-a_fig6_329767507

Intravoxel incoherent motion (IVIM) diffusion‐weighted imaging in...

While it effectively localizes primary tumors, MRI faces problems with diagnosing recurrent gliomas, often failing to distinguish between tumor recurrence ...

5.

ancora.ai

ancora.ai/it/details/NCT06101069

Development of MRF for Characterization of Brain Tumors ...

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.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7757509/

Intravoxel incoherent motion magnetic resonance imaging

According to some authors, IVIM may be used to differentiate radiation necrosis from tumour progression in brain metastases that are treated with stereotactic ...

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researchgate.net

researchgate.net/publication/395897795_Magnetic_Resonance_Fingerprinting_and_IVIM_for_Differentiating_Radiation_Necrosis_from_Tumor_Recurrence_A_Preliminary_Study

Magnetic Resonance Fingerprinting and IVIM for ...

Magnetic Resonance Fingerprinting and IVIM for Differentiating Radiation Necrosis from Tumor Recurrence: A Preliminary Study. September 2025 ...