Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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, individuals with previously untreated 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. * To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 60
Healthy Volunteers: t
View:

• No history of cerebrovascular disease.

• No cognitive impairments.

• Able to provide informed consent.

• Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR

• a. PET identified with developed recurrent tumor or radiation necrosis. OR

• b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.

• ECOG performance status 0-2.

• Life expectancy \> 6 months.

• Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.

• Radiology identified with developed primary gliomas tumor or brain metastases, OR

• a. PET identified with developed gliomas tumor or brain metastases, OR

• b. Highly suspicious case with developed gliomas tumor or brain metastases confirmed by tumor board

• Participants must not have received prior radiation or surgical treatment for brain metastases or primary glioma.

• Age: 21 years and over

• ECOG performance status 0-2

• Life expectancy \> 6 months.

• Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.

Locations
United States
Ohio
Cleveland Clinic Taussig Cancer Center
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Lan Lu, PhD
TaussigResearch@ccf.org
1-866-223 8100
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2026-06
Participants
Target number of participants: 60
Treatments
Experimental: Healthy Volunteer Participants
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.
Experimental: Participants with Radiation Necrosis
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
Experimental: Participants with Tumor Recurrence
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
Experimental: Participants with Brain Metastases
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
Experimental: Participants with Primary Gliomas
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
Sponsors
Leads: Case Comprehensive Cancer Center
Collaborators: The Cleveland Clinic

This content was sourced from clinicaltrials.gov