What this study is
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 see infiltrating tumor. In this safety study, the investigators will carry out increased levels of pH based resections of infiltrating tumor to assess the tolerability in VA populations.
What's being tested
- pH MRI based resection of GBM
Intervention · PROCEDURE
This will require a chemical exchange saturation transfer MRI followed by surgical resection based on this MRI.
Study details
- Official title
- Targeting Infiltrating Glioblastoma Via pH Sensitive Visualization of Tumor and pH Modulation Through Bicarbonate Transporter SLC4A4
- Sponsor
- VA Office of Research and Development
- Conditions
- Glioblastoma
- Enrolling
- 12 people
- Starts
- 2026-07-01
- Est. completion
- 2031-07-01
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
- Kunal S Patel · Contact310-478-3711kunal.patel22@va.gov
- Kunal S Patel · Principal investigator
Study team
Sponsor
VA Office of Research and Development
Study ID ONCE-002-25S
Principal investigator
Kunal S Patel
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.