Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas (NCT03542409) | Clinical Trial Compass
CompletedEarly Phase 1
Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas
United States53 participantsStarted 2017-02-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Imaging Completion
Timeframe: 1 day
2
Incidence of Patient Complications Following Tumor Resection