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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT05864534
Eligibility Criteria:
Inclusion Criteria:
* Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1/2 wild-type
* Tumor with methyl guanine methyl transferase (MGMT) gene promoter unmethylated
* Available paraffin embedded tumor tissue for the study
* Have completed standard radiotherapy with or without temozolomide
* 18 years of age or older
* Able to undergo contrast-enhanced MRI
* Have an Eastern Cooperative Oncology Group/World Health Organization performance status ≤ 2
* Size and location of the residual tumor and/or resection cavity must allow to be able to be covered by the sonication field
* Have not received any prior treatment with immunotherapeutic agents treatments for glioblastoma or other indications
* Have the ability to understand and willingness to sign a written informed consent prior to registration on study.
* Be willing and able to comply with the protocol.
* Have adequate organ and bone marrow function
* Agree to use adequate contraception if appropriate
Exclusion Criteria: Patients will be ineligible if they have:
* Multifocal tumor (unless all localized in a 50-mm diameter area accessible to ultrasound field) or tumor located in the posterior fossa.
* Uncontrolled epilepsy.
* Received other investigational agents within 2 weeks of registration
* Received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.
* Contraindication to checkpoint inhibitor therapy (e.g., history of autoimmune disease)
* Uncontrolled illness
* History of active malignancy other than the brain tumor within 12 months prior to registration.
* Are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05864534
Study Brief:
Protocol Section:
NCT05864534