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NCT06455189 | NOT YET RECRUITING | Glioblastoma


Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
Sponsor:

Case Comprehensive Cancer Center

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.

Condition or disease

Glioblastoma

Brain Tumor

Intervention/treatment

Control Group - Standard of care neurosurgical resection

MRF/MRI infiltration guidance for extended resection

Phase

PHASE1

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
Estimated Enrollment : 114 participants
Masking : SINGLE
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.
Primary Purpose : TREATMENT
Official Title : Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2029-06-01
Estimated Study Completion Date : 2029-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

Location Details

NCT06455189


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Locations


Not yet recruiting

United States, Ohio

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

Cleveland, Ohio, United States, 44106

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