Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

Trial Title: Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

NCT ID: NCT06455189

Condition: Glioblastoma
Brain Tumor

Conditions: Official terms:
Glioblastoma

Conditions: Keywords:
Radiation Therapy
Magnetic Resonance Fingerprinting
MRI

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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.

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:

Intervention type: Other
Intervention name: Control Group - Standard of care neurosurgical resection
Description: 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).
Arm group label: Group 1

Intervention type: Procedure
Intervention name: MRF/MRI infiltration guidance for extended resection
Description: 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
Arm group label: Group 2

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 .

Criteria for eligibility:
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. Exclusion Criteria: - 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.

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospitals Cleveland Medical Center, UH Department of Radiology, Case Comprehensive Cancer Center

Address:
City: Cleveland
Zip: 44106
Country: United States

Contact:
Last name: Chaitra Badve, MD

Phone: 216-844-3312
Email: Chaitra.Badve@uhhospitals.org

Start date: December 2024

Completion date: December 31, 2029

Lead sponsor:
Agency: Case Comprehensive Cancer Center
Agency class: Other

Source: Case Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06455189