A Phase 3 interventional study of Chemical Exchange Saturation Transfer Magnetic Resonance Imaging and Contrast-enhanced Magnetic Resonance Imaging in Glioblastoma, sponsored by Jonsson Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 3, Interventional, and Treatment
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.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 60 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
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Exclusion Criteria:
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 PO for 6 weeks. Additionally, patients undergo MRI during follow up.
Procedure: Contrast-enhanced Magnetic Resonance Imaging · Procedure: Magnetic Resonance Imaging · Radiation: Radiation Therapy · Procedure: Surgical Procedure · Drug: Temozolomide
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.
Procedure: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging · Procedure: Magnetic Resonance Imaging · Radiation: Radiation Therapy · Procedure: Surgical Procedure · Drug: Temozolomide
Undergo CEST MRI
Also known as: Chemical Exchange Saturation Transfer MRI
Undergo contrast-enhanced MRI
Also known as: CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With Contrast
Undergo MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo standard of care radiation therapy
Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Undergo surgical resection
Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
Given PO
Also known as: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temizole, Temodal, Temodar, Temomedac, TMZ
Progression free survival
Multivariate cox and log rank tests will be used to compare progression free survival.
Time frame: Up to 2 years
Overall survival
Multivariate cox and log rank tests will be used to compare overall survival.
Time frame: Up to 2 years
Surgical complication rate
Independent sample Chi-squared tests will be used to compare differences in surgical complication rate.
Time frame: Up to 2 years
Quality of life: Karnofsky Performance Status
Independent sample Chi-squared tests will be used to compare differences in post-operative Karnofsky performance scale changes. The Karnofsky Performance Status (KPS) is a standardized measure used to assess a patient's ability to perform everyday tasks. It ranges from 0 to 100, with higher scores indicating better function.
Time frame: Up to 2 years
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center