Status:
RECRUITING
PH Sensitive MRI Based Resections of Glioblastoma
Lead Sponsor:
University of California, Los Angeles
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This is a single center, single arm, phase 1 surgical dose escalation clinical trial with a preliminary efficacy study at the recommended safe maximal resection. Total duration of subject participatio...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female ≥ 18 years of age.
- 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.
- Karnofsky Performance Scale (KPS) \> 70 (indicating good performance status).
- 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:
- Male or female \< 18 years of age
- 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.
- Not medically cleared for surgery as defined by standard pre-operative neurosurgery guidelines for open craniotomy for resection (not-biopsy) of tumor.
- 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
Exclusion
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06176066
Start Date
August 5 2025
End Date
July 1 2030
Last Update
August 11 2025
Active Locations (1)
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1
Ronald Reagan Medical Center
Los Angeles, California, United States, 90095