Clinical trial · Interventional
A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed With Stereotactic Radiosurgery (SRS)
A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed Primarily With Stereotactic Radiosurgery (SRS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Loss of funding
Summary
Brief summary (as posted)
The purpose of this study is to find out what effects, good and/or bad, stereotactic radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of giving radiation therapy to the brain in a very focused way, so that nearby parts of the brain receive very little exposure to radiation. No incisions are involved. Imaging technology is used to pinpoint the location of the tumor. In this study, the investigators are also trying to find out how the tumor and/or treatment affect brain function over time. The investigators will do this by performing a series of neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before treatment and at regular intervals after treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiosurgery (SRS) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiosurgery (SRS)
- description
- Stereotactic radiosurgery technique via Gamma Knife® Perfexion™ radiosurgical system
- interventionNames
- Other: Stereotactic radiosurgery (SRS)
Primary outcomes (2)
- measure
- Gamma knife radiosurgery treatment
- timeFrame
- Baseline and 6-months following treatment
- description
- Two short oNCF assessments will be performed at least 30 minutes prior to a clinical neurocognitive function (cNCF) assessments directed by a neuropsychologist at baseline and 6 months following Gamma knife treatment to assess changes in the participants' ability to complete all assessments.
- measure
- Validation: To estimate consistency in change in z-scores for online oNCF and comprehensive clinical neurocognitive function (cNCF) neurocognitive assessments at baseline and 6-months in the office/clinic setting.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological confirmation is required (e.g. from extra- or intracranial disease). * Patients with 1-10 measurable brain metastases on a diagnostic-quality contrast-enhanced magnetic resonance imaging (MRI) scan obtained within 30 days prior to registration. * Patients with ≤10 cc largest tumor volume, and ≤15 cc total tumor volume. * History/physical examination within 30 days prior to registration. * If an open biopsy is performed, the patient must be at least one week post biopsy. This requirement does not apply to patients who undergo stereotactic biopsies. * Age ≥18 years. * Karnofsky performance status ≥70 (RTOG recursive partitioning analysis (RPA) Class I \& II). * Minimum pre-treatment oNCF score ≥70. * Patients must provide study-specific informed consent prior to study entry. * Women of child-bearing age must have a negative, quantitative serum pregnancy test ≤14 days prior to study entry, or have a documented reason why such a test is not necessary (e.g. history of tubal ligation). * Patients must be able to speak and read English fluently (required for the use of online NCF testing). Exclusion Criteria: * Clinical (e.g. multiple cranial nerve deficits in the absence of obvious radiographic disease to explain symptoms) or radiographic evidence of leptomeningeal disease. * Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy * No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received. Note: This does not apply to patients with synchronous metastases at initial diagnosis. * Contraindication to MR imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration. * Estimated glomerular filtration rate (eGFR) \<60 within 6 weeks prior to registration. * Prior radiation therapy to the brain. * Severe, active co-morbidity, defined as follows: * Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months. * Transmural myocardial infarction within the last 6 months. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization, or precluding study therapy at the time of registration. * Uncontrolled, clinically significant cardiac arrhythmias. * Radiologic or clinical evidence of hydrocephalus, or history of previously treated hydrocephalus. * Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study is potentially teratogenic.
References
Publications (0)
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