This trial studies how well image-guided surgery using perfusion magnetic resonance imaging (MRI) or alpha-hydroxyglutarate (2-HG) MR spectroscopy works in imaging patients with grade II-IV gliomas. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body, including the brain. These pictures can show the difference between normal and diseased tissue. Finding out more about different imaging methods such as MR perfusion and 2-HG MR spectroscopy may aid doctors in improving surgical treatment, as well as chemotherapy and radiation therapy for gliomas.
Additional locations may be listed on ClinicalTrials.gov for NCT03542409.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Assess the parameters from preoperative and intraoperative MR imaging (dynamic contrast-enhanced MRI [DCE-MRI], dynamic susceptibility contrast MRI [DSC-MRI], 2-HG MR spectroscopy, and diffusion weighted imaging/apparent diffusion coefficient [DWI/ADC] histograms) that may guide extent of resection (EOR) maximization of gliomas.
II. Compare areas from initial surgery with that of extended resection after intraoperative standard of care (SOC) MRI in 10 additional subjects. (Cohort 2)
SECONDARY OBJECTIVE:
I. Assess the effect of preoperative and intraoperative MR image-guided EOR maximization of gliomas on overall and progression-free survival.
EXPLORATORY OBJECTIVES:
I. Assess the parameters from preoperative and intraoperative MR imaging (DCE-MRI, DSC-MRI, 2-HG MR spectroscopy, and DWI/ADC histograms) that may guide minimization of patient complications.
II. Assess the effect of preoperative and intraoperative MR image-guided EOR maximization of gliomas on quality of life.
III. Correlate various tumor and peritumoral areas assessed with MR imaging techniques with 2-HG expression and hypoxia biomarkers/expression signatures from intraoperatively sampled tissue, comparing areas from initial surgery with that of extended resection guided by intraoperative imaging techniques.
OUTLINE: Patients are assigned to 1 of 2 groups.
COHORT 1 GROUP A (contrast enhancing): Patients undergo MR perfusion, as well as standard of care DWI/ADC mapping, and stereotactic MRI before surgery. Patients may also undergo MRI during surgery at the discretion of the treating physician.
COHORT 1 GROUP B (non-enhancing): Patients undergo 2-HG spectroscopy, as well as standard of care DWI/ADC mapping, and stereotactic MRI before surgery. Patients may also undergo MRI during surgery at the discretion of the treating physician.
COHORT 2: Patients undergo SOC MRI during surgery and then transition to standard of care follow-up.
After completion of study intervention, cohort 1 patients are followed up at days 30-60, 120, 180, and 365.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorRandy Lynn Jensen
