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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07438860
Eligibility Criteria:
Inclusion Criteria:
* Participants must have suspected or confirmed untreated malignant brain tumors
* Participants must have received no prior therapies for this disease.
* Participants are 18 years of age or older. Because no dosing or adverse event data are currently available on the use of SBK2-ICG in individuals under 18 years of age, children are excluded from this study.
* Karnofsky Performance status ≥ 60%
* Glioma is located in the supratentorial region of the brain.
* Tumor is suitable for resection on the basis of imaging studies and participant and surgeon must plan resection
* Able and willing to undergo MRI scan.
* Participants must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Pregnant individuals or those who are breast feeding.
* Individuals with AST, ALT, ALP, or bilirubin \>2.5x normal upper limit any time during the previous 2 months.
* Individuals with plasma creatinine \> 2.5 mg/dL.
* Individuals without a probable or expected grade IV glioma.
* Individuals not planning surgery on glioma.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG or other agents used in this study.
* Note: A baseline blood sample will be drawn for creatinine, AST, ALT, ALP, and bilirubin to verify whether or not this exclusion criterion is met.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07438860
Study Brief:
Protocol Section:
NCT07438860