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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 belowSelect...
I am older than 18.
Select...
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:Select...
I have received treatment for glioblastoma before.
Select...
I am unable to give consent for Stage II of the study.
Select...
I cannot undergo surgery due to health risks.
Select...
I had a minor surgery or biopsy for my condition.
Select...
My glioma has come back or was treated before and is Stage II.
Select...
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
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 moreTrial 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
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
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