Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT04895592
Eligibility Criteria:
Inclusion Criteria:
* Age \>= 18 years
* Prior or suspected diagnosis of malignancy
* Brain metastases visible on contrasted magnetic resonance imaging (MRI) brain
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Life expectancy \> 12 weeks as determined by the investigator
* Patients must have adequate organ function as determined by Neurosurgery to undergo surgery
* Willingness and ability of the subject to comply with scheduled visits, study procedures, and study restrictions
* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
* Patient must have a negative pregnancy test, be actively taking oral contraceptives or have undergone a hysterectomy
Exclusion Criteria:
* Patients on any immunosuppressive medication other than dexamethasone
* Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Human immunodeficiency virus (HIV)-positive
* Pregnant or nursing women are excluded
* Prior whole brain radiotherapy or SRS to the same site planned for surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04895592
Study Brief:
Protocol Section:
NCT04895592