Brain Tumor Adult
Conditions
Brief 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.
Interventions
DEVICEMR Perfusion Scan
MR perfusion scan before and during surgery.
DEVICE2HG Spectroscopy Scan
2HG spectroscopy scan before and during surgery.
DEVICEStandard of Care Intraoperative MRI
The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples.
Sponsors
University of Utah
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Imaging Completion | 1 day | This is a feasibility study to see whether advanced imaging modalities can be used intraoperatively so the primary outcome is a yes/no regarding completion of imaging. |
| Incidence of Patient Complications Following Tumor Resection | 1 year | Any surgical complications at post-op, hospital discharge, 1-month, 3-months, 6-months, and 1 year following surgery using the Common Terminology Criteria for Adverse Events (CTCAE) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRandy Jensen, MD, PhD
Huntsman Cancer Institute
Outcome results
None listed