pH-sensitive MRI-guided resection for glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.