pH-sensitive MRI-guided resection for glioblastoma

PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma

This trial will test whether using a pH-sensitive MRI scan (CEST‑EPI) to guide more extensive surgery can help adults with newly diagnosed or recurrent IDH‑wildtype glioblastoma by finding and removing infiltrative tumor beyond standard imaging.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06176066 on ClinicalTrials.gov

What this trial studies

This is a single-center, single-arm Phase 1 surgical dose-escalation trial with a preliminary efficacy cohort at the recommended maximal resection. Patients undergo standard preoperative imaging plus a CEST‑EPI pH-sensitive MRI whose processed maps are imported into intraoperative neuronavigation to highlight potentially infiltrative, non-enhancing tumor. Surgeons will expand resection margins in staged increments (starting at 0.7 cm up to 2.8 cm) guided by the pH map and navigational system. Participants are adults with suspected newly diagnosed or recurrent IDH‑wildtype glioblastoma and will be followed for two years after surgery.

Who should consider this trial

Good fit: Adults (≥18) with suspected newly diagnosed or recurrent IDH‑wildtype glioblastoma, KPS >70, and who are medically cleared for open craniotomy at the enrolling center are the intended participants.

Not a fit: Patients with tumors involving eloquent brain regions where extended resection is unsafe, those who are not candidates for open resection, or patients with IDH‑mutant tumors or poor performance status are unlikely to benefit.

Why it matters

Potential benefit: If successful, the technique could reveal otherwise hidden infiltrative tumor and enable safer, more complete resections that may prolong progression-free and overall survival.

How similar studies have performed: Prior work has used CEST pH imaging to map tumor acidity, but using pH-sensitive MRI to direct expanded surgical resection is novel and supported mainly by preliminary data.

Eligibility criteria

Inclusion Criteria

1. Male or female ≥ 18 years of age.
2. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
3. Karnofsky Performance Scale (KPS) \> 70 (indicating good performance status).
4. Individuals with suspected, newly diagnosed or recurrent IDH wild type WHO IV glioblastoma (intraxial, expansile contrast-enhancing mass without evidence of metastatic disease. This will be reviewed by UCLA neuroradiology to only include patients with high likelihood of GBM)

Exclusion Criteria:

1. Male or female \< 18 years of age
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Not medically cleared for surgery as defined by standard pre-operative neurosurgery guidelines for open craniotomy for resection (not-biopsy) of tumor.
4. Involvement of eloquent areas (as defined by MRI signal clearly involving areas that would lead to a qualifying neurologic deficit as defined in surgical limiting toxicity - this will specifically include: 1) primary motor cortex, 2) primary sensory cortex, 3) sensorimotor fibers as defined on diffusion tensor imaging, 4) primary language areas (Broca, Wernicke), 5) arcuate fasiculus as defined on diffusion tensor imaging

Where this trial is running

Los Angeles, California

• Ronald Reagan Medical Center — Los Angeles, California, United States (Recruiting)

Conditions Glioblastoma; glioblastoma; magnetic resonance imaging; advanced imaging; surgical oncology