Brain Tumor, Glioblastoma
Conditions
Keywords
Radiation Therapy, Magnetic Resonance Fingerprinting, MRI
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 .
Interventions
OTHERControl Group - Standard of care neurosurgical resection
The control group will include only standard of care tools. - Standard of care neurosurgical resection will include the use of all standard neurosurgical instruments and techniques (eg, microscope, intraoperative ultrasound, 5-ALA fluorescence guided surgery and neuronavigation system).
PROCEDUREMRF/MRI infiltration guidance for extended resection
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
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The neurosurgeons and participants will not be masked to the treatment group assignment, but the team members looking at outcome assessment will be blinded.
Intervention model description
Participants will be randomly allocated in a one-to-one ratio to undergo either tumor resection with intraoperative MRF/MRI infiltration mapping guidance or with standard of care neurosurgical techniques. The investigators who assess eligibility of participants and schedule surgeries (neurosurgeons, residents, research nurse) will be masked to treatment group assignment by use of a sealed-envelope design. The treatment group assignments will be disclosed after surgery is scheduled and after written consent is obtained, usually on the day before the operation.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage I: Inclusion criteria: * 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 * Consideration for biopsy, subtotal or gross total resection.
Exclusion criteria
* Contraindications to MRI * Contraindication to surgical treatment * Prior treatment for glioblastoma Stage II: Inclusion Criteria: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Histopathological correlation | Approximately one week post surgery | — |
| Recurrence | Approximately 12 months post surgery | As assessed by MRI scans |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChaitra Badve, MD
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORTiffany Hodges, MD
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Outcome results
None listed