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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT01861405
Eligibility Criteria:
Inclusion Criteria:
* Patients with a cumulative intracranial disease burden of up to but not exceeding 8cc.
* Patients with newly diagnosed brain metastases are undergoing WBRT or SRS as previously determined by their oncologist and or radiation oncologist.
* Right or left hand dominance.
* Karnofsky performance status (KPS) equal to or greater than 70.
* 70 years old or younger.
* All non-hematopoietic histologies except melanoma and renal cell carcinoma.
* Brainstem lesions are acceptable.
* Normal renal function to tolerate a contrast enhanced MRI scan.
* Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
* Age less than 18 years old.
* KPS \<70.
* Pregnant female.
* Active systemic disease.
* Age greater than 70 years old.
* Patients with leptomeningeal metastases.
* Contraindication for MRI such as implanted metal devices, foreign bodies or severe claustrophobia or axial back pain precluding a prolonged MRI study.
* Prior radiation therapy to the brain.
* Poor renal function rendering contrast enhanced MRI un-obtainable.
* Histological diagnosis of small cell lung cancer.
* Craniotomy or other major surgery within 2 weeks of start of either SRS or WBRT.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01861405
Study Brief:
Protocol Section:
NCT01861405