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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT07053033
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document.
* Willingness to comply with all study procedures and availability for the duration of the study.
* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study.
* Karnofsky performance status ≥ 60.
* Radiographic concern for progression of a solid tumor brain metastasis that has received prior stereotactic radiosurgery ≥ 3 months prior to study enrollment.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm with MRI scan.
* Have active tumor on pathology from surgery/LITT for this lesion.
* Able to safely undergo MRI imaging.
* Acceptable candidate for SRS2 per treating physician and multidisciplinary conference consensus.
* Have no radiographic evidence of leptomeningeal disease on radiology report or neuro-radiologist review.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion Criteria:
* Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms.
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. All female patients between the onset of menses and 55 years will receive a pregnancy test prior to SRS2 unless the patient presents with an applicable exclusionary factor which may be one of the following:
* Postmenopausal (no menses in greater than or equal to 12 consecutive months).
* History of hysterectomy or bilateral salpingo-oophorectomy.
* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
* History of bilateral tubal ligation or another surgical sterilization procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07053033
Study Brief:
Protocol Section:
NCT07053033