Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06101069

Recruiting

Development of MRF for Characterization of Brain Tumors After Radiotherapy

Interventional

Phase not listed

Cleveland Clinic Taussig Cancer Center

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.

Show Detailed Description

Treatment Category

Procedure

Required Mutations

None

Trial Started

2024-10-14

Last Updated by Sponsor

2025-06-06

Estimated Completion

2025-12-01

Eligibility

Inclusion Criteria

* 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.

Inclusion Criteria for Participants with Brain Metastases or Primary Gliomas:

* 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.

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.

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Design Details

AllocationNon-Randomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll60

Arms & Interventions

Arms

Interventions

Type: Experimental

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.

Interventions:

MRF in conjunction with IVIM MRI without contrast

Outcome Measures

Primary Outcome Measures

Comparison of T1 relaxation timesWithin the total 30-45 minute scan time

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 timesWithin the total 30-45 minute scan time

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 mapsWithin the total 30-45 minute scan time

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 tissuesWithin the total 30-45 minute scan time

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 tissuesWithin the total 30-45 minute scan time

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.

Comparison of MRF imaging tool in different participant populationsWithin the total 30-45 minute scan time

The objective is to compare the effects of radiation dose on development of radiation and necrosis and tumor recurrence by comparing participants in all cohorts (healthy participants with no brain disease, participants with brain tumors (treated), participants with brain metastases or primary gliomas (previously untreated)). The predictive ability will be assessed by comparing univariable ROC analysis, quantified using area under the curve (AUC).

Secondary Outcome Measures

None

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Trial Sites

This study has 2 trial sites

Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, US

Recruiting

Cleveland, Ohio, 44195 US

Cleveland Clinic Taussig Cancer Center

Recruiting

Cleveland, Ohio, 44106 US

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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