Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

NCT06455189 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: CASE1324
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Brain Tumor

Keywords

Radiation Therapy; Magnetic Resonance Fingerprinting; MRI

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Progression Free Survival(PFS)

  6 months

• Extent of resection

  1 week post surgery

• Operator confidence

  1 week post surgery

• Histopathological correlation

  Approximately one week post surgery

• Recurrence

  Approximately 12 months post surgery

Study Arms (2)

Group 1

OTHER

Routine standard of care process will be followed for neurosurgical guidance

Other: Control Group - Standard of care neurosurgical resection

Group 2

EXPERIMENTAL

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

Interventions

Control Group - Standard of care neurosurgical resection 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 1

MRF/MRI infiltration guidance for extended resection 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

Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindications to MRI
• Contraindication to surgical treatment
• Prior treatment for glioblastoma
• Stage II:
• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Chaitra Badve, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Tiffany Hodges, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaitra Badve, MD

CONTACT

216-844-3312; Chaitra.Badve@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The neurosurgeons and participants will not be masked to the treatment group assignment, but the team members looking at outcome assessment will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)