Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

NCT ID: NCT06455189

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-12-31

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 .

Conditions

Glioblastoma; Brain Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Routine standard of care process will be followed for neurosurgical guidance

Group Type: OTHER

Control Group - Standard of care neurosurgical resection

Intervention Type: OTHER

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).

Group 2

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 Type: EXPERIMENTAL

MRF/MRI infiltration guidance for extended resection

Intervention Type: PROCEDURE

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

Interventions

Control 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).

Intervention Type: OTHER

MRF/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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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

• Contraindications to MRI
• Contraindication to surgical treatment
• Prior treatment for glioblastoma

Stage II:

• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chaitra Badve, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Tiffany Hodges, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

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

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Chaitra Badve, MD

Role: CONTACT

Chaitra.Badve@uhhospitals.org

216-844-3312

Facility Contacts

Chaitra Badve, MD

Role: primary

Chaitra.Badve@uhhospitals.org

216-844-3312

Other Identifiers

CASE1324

Identifier Type: -

Identifier Source: org_study_id