Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-005248
NCT ID: NCT03621748
Sponsor Protocol Number: 18-005248
About this study
The purpose of this study is to compare local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with age ≥18 years old.
- WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic resonance imaging (MRI) and determined by an independent brain surgeon (Dr. Ron Reimer).
- An elective procedure.
- A single lesion.
- No major comorbidities that would necessitate an extended hospital stay.
- Newly diagnosed tumors.
Exclusion Criteria:
- Patients with age < 18 years old.
- Non-gliomas.
- Eloquent location (motor, sensory, language).
- Non-elective procedure.
- Multiple lesions.
- Major comorbidities.
- Recurrent tumors.
- Patients lacking capacity to consent.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Kaisorn Chaichana, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available