PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma
Jonsson Comprehensive Cancer Center
Summary
This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.
Description
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 foll…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 medica…
Interventions
- ProcedureChemical Exchange Saturation Transfer Magnetic Resonance Imaging
Undergo CEST MRI
- ProcedureContrast-enhanced Magnetic Resonance Imaging
Undergo contrast-enhanced MRI
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- RadiationRadiation Therapy
Undergo standard of care radiation therapy
- ProcedureSurgical Procedure
Undergo surgical resection
- DrugTemozolomide
Given PO
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California