Status:
NOT_YET_RECRUITING
Phase I Trial of pH Resections of GBM at VA
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Glioblastoma is an infiltrating tumor that is difficult to visualize in surgery and on standard images. A special pH (acid-base) related magnetic resonance imaging (MRI) has been developed to better s...
Detailed Description
Current standard of care therapy and all FDA approved adjuvant therapy for glioblastoma continue to provide less than 12 months of progression free survival (PFS) and less than 24 months of overall su...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent
- Karnofsky Performance Scale (KPS) of 70 or higher
- Suspected, newly diagnosed or recurrent IDH wild type WHO IV glioblastoma presenting as an intra-axial
- Expansile contrast-enhancing mass without evidence of metastatic disease
Exclusion
- Diagnostic uncertainty such as history of extracranial malignancy or autoimmune disease
- Medical conditions prohibiting anesthesia or surgery
- Tumors involving eloquent brain areas as defined by MRI signal
- primary motor cortex, primary sensory cortex, sensorimotor fibers, primary language areas, arcuate fasciculus
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07218367
Start Date
February 1 2026
End Date
February 1 2031
Last Update
December 24 2025
Active Locations (1)
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1
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003