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Development of MRF for Characterization of Brain Tumors After Radiotherapy

Primary Purpose

Brain Tumor, Brain Necrosis, Brain Metastases

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRF in conjunction with IVIM MRI without contrast
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Magnetic Resonance Fingerprinting, Radiation necrosis

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Healthy Participants: No history of cerebrovascular disease. No cognitive impairments. Able to provide informed consent. Inclusion Criteria for Participants with Brain Tumors: 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. Exclusion Criteria: Pregnant women OR lactating women Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips. Participants who cannot go into the MRI scanner due to metal implants and other medical conditions. The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator. Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material. Known history of severe claustrophobia. Participants unable to lay still in the scanner for 30 minutes at a time.

Sites / Locations

  • Cleveland Clinic Taussig Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy Volunteer Participants

Participants with Radiation Necrosis

Participants with Tumor Recurrence

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Comparison of T1 relaxation times
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T1 relaxation times. The difference in mean T1 between each cohort of participants will be measured.
Comparison of T2 relaxation times
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T2 relaxation times. The difference in mean T2 between each cohort of participants will be measured.
Comparison of proton density maps
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the MRF proton density maps of each cohort of participants. This will be compared using a t-test.
Comparison of water diffusion in brain tissues
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the diffusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Comparison of blood perfusion in brain tissues
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the perfusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2023
Last Updated
October 20, 2023
Sponsor
Case Comprehensive Cancer Center
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT06101069
Brief Title
Development of MRF for Characterization of Brain Tumors After Radiotherapy
Official Title
Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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, 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.
Detailed Description
Although Stereotactic radiosurgery (SRS) is utilized as an effective treatment method, after several months to over 1 year following SRS, 33% of treated brain metastases increase in size on imaging, which is suspicious for tumor progression. However, based on findings in follow-up biopsies, the majority of newly detected metastases on imaging are radiation treatment effects instead of active tumor. So far, the only gold standard to differentiate active tumor and radiation necrosis is surgical resection for pathologic confirmation, which is invasive, not favored for poor surgical candidates, and should be avoided in cases of necrosis. The existing clinical imaging techniques have poor sensitivity or specificity in differentiating these two types of tissues. Recently, a novel MRI data acquisition approach, namely MR Fingerprinting (MRF), has been introduced for the simultaneous measurement of multiple important parameters in a single MRI scan. In addition, quantitative diffusion MRI, such as the intravoxel incoherent motion (IVIM) technique, can provide a noninvasive and powerful tool to quantify microstructural information by measuring water diffusion and microcirculation perfusion in vivo. This study aims 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. It also aims to apply the developed quantitative approach in combination with IVIM MRI for the differentiation of tumor recurrence and radiation necrosis. The multi-parametric quantitative measures developed in this study could establish a new fundamental biomarker for the diagnosis and monitoring of brain tumors

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Brain Necrosis, Brain Metastases
Keywords
Magnetic Resonance Fingerprinting, Radiation necrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, observational, multi-cohort, unblinded, single-center study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteer Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants with Radiation Necrosis
Arm Type
Experimental
Arm Description
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
Arm Title
Participants with Tumor Recurrence
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
MRF in conjunction with IVIM MRI without contrast
Intervention Description
MRF in conjunction with IVIM MRI scan, without contrast.
Primary Outcome Measure Information:
Title
Comparison of T1 relaxation times
Description
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T1 relaxation times. The difference in mean T1 between each cohort of participants will be measured.
Time Frame
Within the total 30-45 minute scan time
Title
Comparison of T2 relaxation times
Description
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T2 relaxation times. The difference in mean T2 between each cohort of participants will be measured.
Time Frame
Within the total 30-45 minute scan time
Title
Comparison of proton density maps
Description
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the MRF proton density maps of each cohort of participants. This will be compared using a t-test.
Time Frame
Within the total 30-45 minute scan time
Title
Comparison of water diffusion in brain tissues
Description
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the diffusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Time Frame
Within the total 30-45 minute scan time
Title
Comparison of blood perfusion in brain tissues
Description
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the perfusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Time Frame
Within the total 30-45 minute scan time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Healthy Participants: No history of cerebrovascular disease. No cognitive impairments. Able to provide informed consent. Inclusion Criteria for Participants with Brain Tumors: 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. Exclusion Criteria: Pregnant women OR lactating women Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips. Participants who cannot go into the MRI scanner due to metal implants and other medical conditions. The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator. Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material. Known history of severe claustrophobia. Participants unable to lay still in the scanner for 30 minutes at a time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Lu, PhD
Phone
1-866-223 8100
Email
TaussigResearch@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lan Lu, PhD
Organizational Affiliation
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel Chao, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Lu, PhD
Phone
866-223-8100
Email
TaussigResearch@ccf.org
First Name & Middle Initial & Last Name & Degree
Lan Lu, PhD
First Name & Middle Initial & Last Name & Degree
Samuel Chao, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Development of MRF for Characterization of Brain Tumors After Radiotherapy

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