PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma

PRIMARY OBJECTIVE:

I. To assess the efficacy of potential of hydrogen (pH) sensitive MRI based resections of glioblastoma.

SECONDARY OBJECTIVE:

I. To find surgical and adjuvant therapies to treat infiltrating glioblastoma cells.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo surgical resection with standard intraoperative guidance using contrast-enhanced MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide orally (PO) for 6 weeks. Additionally, patients undergo MRI during follow up.

GROUP II: Patients undergo surgical resection with intraoperative guidance using CEST MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up.

After completion of study treatment, patients are followed up at months 3, 6, 12, and 24.

Inclusion criteria

• Male or female ≥ 18 years of age
• Documentation of a newly diagnosed World Health Organization (WHO) grade IV glioblastoma as evidenced by clinical features and imaging data
• 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

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
• Previous treatment (any chemotherapy, molecular therapy, immunotherapy, or radiation therapy)