40 Participants Needed

MRF + IVIM MRI for Brain Cancer

Recruiting at 1 trial location
LL
Overseen ByLan Lu, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

Is 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.24678

How 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.1591011

Research Team

Samuel Chao, MD | Cleveland Clinic

Samuel T. Chao, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

LL

Lan Lu, PhD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility 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.
See 5 more

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

Treatment Details

Interventions

  • MRF in conjunction with IVIM MRI
Trial OverviewThe 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.
Participant Groups
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:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as MRF with IVIM MRI for:
  • Diagnostic imaging for brain tumors
  • Differentiation of tumor recurrence and radiation necrosis
๐Ÿ‡ช๐Ÿ‡บ
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

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+

Findings from Research

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

References

Initial assessment of 3D magnetic resonance fingerprinting (MRF) towards quantitative brain imaging for radiation therapy. [2020]
Tailored magnetic resonance fingerprinting of post-operative pediatric brain tumor patients. [2023]
Magnetic Resonance Fingerprinting to Characterize Childhood and Young Adult Brain Tumors. [2020]
Magnetic resonance fingerprinting: an overview. [2021]
MR Fingerprinting-A Radiogenomic Marker for Diffuse Gliomas. [2022]
Magnetic Resonance Fingerprinting-An Overview. [2020]
Toward magnetic resonance fingerprinting for low-field MR-guided radiation therapy. [2022]
Feasibility of MR fingerprinting using a high-performance 0.55 T MRI system. [2022]
Glioma grading and IDH1 mutational status: assessment by intravoxel incoherent motion MRI. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Intravoxel Incoherent Motion Metrics as Potential Biomarkers for Survival in Glioblastoma. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Accurate intravoxel incoherent motion parameter estimation using Bayesian fitting and reduced number of low b-values. [2021]