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Completed NCT03542409

Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas

Conditions: Brain Tumor Adult

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 53
Sponsor: University of Utah

Location: Huntsman Cancer Institute Salt Lake City Utah

Summary

This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas. Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively. Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years * Suspected glioma (grade II, III, or IV) * Preoperative MR perfusion (enhancing tumors) * Preoperative MR 2-HG spectroscopy (nonenhancing tumors) * Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care * Karnofsky performance status ≥ 60 * Life expectancy \> 12 weeks * Cohort 1: Ability to comply with study and follow-up procedures * Cohort 2: Ability to comply with study procedures Exclusion Criteria: * Prior diagnosis of intracranial glioma * Other malignancy with expected need for systemic therapy within 3 years * Inability to have 6000 grays of radiation to the brain * Need for urgent palliative intervention for primary disease (e.g., impending herniation) * Evidence of bleeding diathesis or coagulopathy * History of intracerebral abscess within 6 months prior to Day 0 * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study * Pregnant females * Subjects unable to undergo an MRI with contrast

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03542409). StuddyBuddy aggregates publicly available trial information.