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MRF-Guided Surgery for Brain Tumors

Phase 1

Waitlist Available

Led By Chaitra Badve, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18

Lesions amenable to gross total resection

Must not have

Prior treatment for glioblastoma

Inability to consent for the study (Stage II)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months post surgery

Awards & highlights

Summary

This trial aims to see if a new method called MR fingerprinting can provide better and more detailed images of brain tumors compared to traditional MRI scans.

Who is the study for?

This trial is for individuals with glioblastoma, a type of brain tumor. Participants should be eligible for neurosurgical resection, the surgical removal of part of the brain to treat their condition.

What is being tested?

The study is testing if Magnetic Resonance Fingerprinting (MRF) can better guide surgeons in removing more of the brain tumor than standard MRI techniques during surgery.

What are the potential side effects?

Since this trial compares different imaging techniques used to guide surgery rather than medications, there are no direct side effects from MRF itself; however, risks associated with neurosurgery may still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18.

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My cancer can be completely removed with surgery.

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My tumor is larger than 3 cm in diameter.

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My brain tumor shows changes on MRI beyond the main tumor area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatment for glioblastoma before.

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I am unable to give consent for Stage II of the study.

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I cannot undergo surgery due to health risks.

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I had a minor surgery or biopsy for my condition.

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My glioma has come back or was treated before and is Stage II.

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I cannot have an MRI scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility as assessed by the performance of MRF/MRI infiltration mapping guidance in surgical resection of new glioblastomas

Number of participants who experienced serious adverse events(SAEs) at 30 days post targeted biopsy sampling procedure

Number of participants who experienced serious adverse events(SAEs) at 48 hours post targeted biopsy sampling procedure

Secondary outcome measures

Extent of resection

Histopathological correlation

Operator confidence

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

The surgeon will have access to advanced MRI and MRF analysis research images during surgery and may use them for guidance, in addition to all routinely used surgical tools.

Group II: Group 1Experimental Treatment1 Intervention

Routine standard of care process will be followed for neurosurgical guidance

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

459 Previous Clinical Trials

32,174 Total Patients Enrolled

16 Trials studying Glioblastoma

446 Patients Enrolled for Glioblastoma

Chaitra Badve, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Tiffany Hodges, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

1 Previous Clinical Trials

34 Total Patients Enrolled

1 Trials studying Glioblastoma

34 Patients Enrolled for Glioblastoma

~76 spots leftby Jun 2029

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