Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
- Conditions
- Brain TumorGlioblastoma
- Interventions
- Other: Control Group - Standard of care neurosurgical resectionProcedure: MRF/MRI infiltration guidance for extended resection
- Registration Number
- NCT06455189
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the brain, better than routine MRI images.
- Detailed Description
Glioblastomas (GBs) are aggressive malignant brain tumors with a median survival of less than 15 months . Infiltration of cancer beyond the tumor margins causes recurrence in nearly 100% of GBs; however, this cannot be measured by current imaging techniques . Availability of reliable and reproducible infiltration prediction maps at initial diagnosis will open new treatment opportunities such as targeted surgery or escalated radiation therapy (RT).
On clinical contrast enhanced (CE) magnetic resonance imaging (MRI) scans, a typical GB demonstrates an enhancing mass with central necrosis and an extensive surrounding, peritumoral region with bright signal on T2-weighted(w) and FLAIR (Fluid attenuation inversion recovery) images. This bright, peritumoral T2/FLAIR region is known to contain vasogenic edema and tumor infiltration, as it is well known that GBs infiltrate beyond the enhancing tumor margins.
Since there is a clear link between extent of tumor resection and survival the challenge for neurosurgeons is maximizing resection of tumor, while avoiding neurological injury. Typically, the central region of the tumor can be safely resected with minimal risk. The challenge lies in maximal safe resection along the tumor margins as it infiltrates normal brain. MR Fingerprinting is a quantitative imaging (QI) scan developed at CWRU that provides rapid quantification of multiple tissue properties, such as T1 and T2 relaxation maps, with high reproducibility and excellent tissue characterization. Our preliminary analysis of retrospective data of 60 GB participants with MRF+MRI scans with targeted 5-aminolevulenic acid (5-ALA) tissue sampling demonstrates an AUC of 0.8 for MRF/MRI model for GBM infiltration prediction in peritumoral region .
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 114
- Age > 18
- MR imaging findings suggestive of GB
- Maximal tumor diameter greater than 3 cm
- Ability to provide written informed consent
- Ability to undergo MRI scan
- Lesions amenable to gross total resection
- Presence of peritumoral FLAIR signal abnormality beyond the area of enhancement.
- Inability to undergo MRI imaging
- Participants undergoing only stereotactic biopsy or less than gross total resection
- Participants undergoing LITT
- Inability to consent for the study
- Previously treated/ recurrent glioma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Control Group - Standard of care neurosurgical resection Routine standard of care process will be followed for neurosurgical guidance Group 2 MRF/MRI infiltration guidance for extended resection 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.
- Primary Outcome Measures
Name Time Method Number of participants who experienced serious adverse events(SAEs) at 30 days post targeted biopsy sampling procedure 30 days post surgery Safety is defined as the absence of significant complications at 30 days. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm
Number of participants who experienced serious adverse events(SAEs) at 48 hours post targeted biopsy sampling procedure 48 hours post surgery Safety is defined as the absence of significant complications at 48 hours. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm
Feasibility as assessed by the performance of MRF/MRI infiltration mapping guidance in surgical resection of new glioblastomas Up to 72 hours post surgery Assessed by post surgical MRI scans
- Secondary Outcome Measures
Name Time Method Recurrence Approximately 12 months post surgery As assessed by MRI scans
Histopathological correlation Approximately one week post surgery Progression Free Survival(PFS) 6 months PFS will be estimated using Kaplan-Meier method and the difference of PFS between two arms will be compared using log-rank test
Extent of resection 1 week post surgery As assessed by post surgical MRI scans
Operator confidence 1 week post surgery
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center, UH Department of Radiology, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States