Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioblastoma; Brain Tumor
• Intervention / Treatment: Other: Control Group - Standard of care neurosurgical resection; Procedure: MRF/MRI infiltration guidance for extended resection

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 .

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chaitra Badve, MD; Phone Number: 216-844-3312; Email: Chaitra.Badve@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, UH Department of Radiology, Case Comprehensive Cancer Center
      • Contact: Chaitra Badve, MD; Phone Number: 216-844-3312; Email: Chaitra.Badve@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Routine standard of care process will be followed for neurosurgical guidance	Other: 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).
Experimental: 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.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who experienced serious adverse events(SAEs) at 48 hours post targeted biopsy sampling procedure	Safety is defined as the absence of significant complications at 48 hours. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm	48 hours post surgery
Number of participants who experienced serious adverse events(SAEs) at 30 days post targeted biopsy sampling procedure	Safety is defined as the absence of significant complications at 30 days. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm	30 days post surgery
Feasibility as assessed by the performance of MRF/MRI infiltration mapping guidance in surgical resection of new glioblastomas	Assessed by post surgical MRI scans	Up to 72 hours post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival(PFS)	PFS will be estimated using Kaplan-Meier method and the difference of PFS between two arms will be compared using log-rank test	6 months
Extent of resection	As assessed by post surgical MRI scans	1 week post surgery
Operator confidence		1 week post surgery
Histopathological correlation		Approximately one week post surgery
Recurrence	As assessed by MRI scans	Approximately 12 months post surgery

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Tiffany Hodges, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; Principal Investigator: Chaitra Badve, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Radiation Therapy; Magnetic Resonance Fingerprinting
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: CASE1324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No