Phase I Trial of pH Resections of GBM at VA

NCT07218367 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: ONCE-002-25S
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Glioblastoma

Keywords

glioblastoma; high grade glioma

Outcome Measures

Primary Outcomes (1)

• Resection related adverse events

  Safety as described by surgical complication rates by the data safety and monitoring board

  1 month

Study Arms (1)

pH Resections

EXPERIMENTAL

This is a single arm study so all patients will receive the intervention

Procedure: pH MRI based resection of GBM

Interventions

pH MRI based resection of GBM PROCEDURE

This will require a chemical exchange saturation transfer MRI followed by surgical resection based on this MRI.

pH Resections

Eligibility Criteria

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

You 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 may not qualify 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Kunal S Patel

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kunal S Patel

CONTACT

(310) 478-3711; kunal.patel22@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: A pH based MRI is carried out, uploaded to intraoperative neuronavigation software, and used in a surgical escalation study to increase amounts of infiltrating pH abnormal tumor removed

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)