Using advanced imaging techniques to improve glioma surgery
Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation
This study is testing if using advanced MRI techniques during glioma surgery can help improve outcomes for patients with brain tumors compared to standard imaging.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT03542409 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of using specialized magnetic resonance imaging (MRI) techniques, including MR perfusion and 2-hydroxyglutarate (2HG) spectroscopy, in the surgical treatment of gliomas. Participants are divided into two cohorts; one will receive advanced imaging prior to and during surgery, while the other will receive standard imaging. The goal is to determine if these advanced imaging techniques can enhance surgical outcomes for patients with brain tumors. The study will conclude after surgery, transitioning participants to standard follow-up care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with suspected gliomas (grades II, III, or IV) who are indicated for surgical resection.
Not a fit: Patients with a prior diagnosis of intracranial glioma or those requiring urgent palliative interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical resections of gliomas, potentially improving patient outcomes.
How similar studies have performed: While the use of advanced imaging techniques in glioma surgery is promising, this specific combination of MR perfusion and 2HG spectroscopy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Elaine Hamel
- Email: elaine.hamel@hci.utah.edu
- Phone: 801-587-4720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.