About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
Procedure/SurgeryUndergo CEST MRI
Contrast-enhanced Magnetic Resonance Imaging
Procedure/SurgeryUndergo contrast-enhanced MRI
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Radiation Therapy
RadiationUndergo standard of care radiation therapy
Surgical Procedure
Procedure/SurgeryUndergo surgical resection
Temozolomide
DrugGiven PO
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival
Multivariate cox and log rank tests will be used to compare progression free survival.
Secondary outcomes
Overall survival
Multivariate cox and log rank tests will be used to compare overall survival.
Surgical complication rate
Independent sample Chi-squared tests will be used to compare differences in surgical complication rate.
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.
Sponsors and contacts
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