Recruiting

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06101069

Conditions

Brain Tumor

Brain Necrosis

Brain Metastases

Glioma

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

MRF in conjunction with IVIM MRI without contrast

Study Details

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, 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.

Conditions

Brain Tumor

Brain Necrosis

Brain Metastases

Glioma

Study ID

NCT06101069

Start date

Oct 14, 2024

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria for Healthy Participants:

  • Ages 18 - 60
  • 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.

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: 18 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.

Inclusion Criteria for Participants with Meningiomas:

  • Radiology identified with resectable meningioma
  • Participants have no prior radiation or surgical treatment for brain lesions
  • Age: 18 years or older
  • ECOG performance status 0-2
  • Life expectancy > 6 months.
  • Participants 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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

experimental: Participants with Meningiomas

The MRI scans (MRF and IVIM) will be performed on participants with meningiomas who have not yet undergone radiation or surgical treatment. 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

Interventions

MRF in conjunction with IVIM MRI without contrast

MRF in conjunction with IVIM MRI scan, without contrast.

Primary outcome measure

  • Comparison of T1 relaxation times [ Time Frame: Within the total 30-45 minute scan time ]
  • Comparison of T2 relaxation times [ Time Frame: Within the total 30-45 minute scan time ]
  • Comparison of proton density maps [ Time Frame: Within the total 30-45 minute scan time ]
  • Comparison of water diffusion in brain tissues [ Time Frame: Within the total 30-45 minute scan time ]
  • Comparison of blood perfusion in brain tissues [ Time Frame: Within the total 30-45 minute scan time ]
  • Comparison of MRF imaging tool in different participant populations [ Time Frame: Within the total 30-45 minute scan time ]

Central Contacts and Locations

Central contacts

Lan Lu, PhD

1-866-223 8100TaussigResearch@ccf.org

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic Taussig Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Lan Lu, PhD

866-223-8100

Principal Investigator:

Lan Lu, PhD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Magnetic Resonance Fingerprinting
  • Radiation necrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-05-05.