The purpose of this study is to determine the effectiveness and efficiency of Single
Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more
Radiation: Stereotactic radiosurgery
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Full eligibility criteria for NCT02886572
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
A contrast-enhanced MRI scan showing = or > 4 brain metastases.
Age >/=18 years of age.
KPS >/= 70
Patient must have a graded prosnostic score (GPA) score 0.5 or greater
Life expectancy of at least 3 months
Postoperative patients with resected brain metastases are eligible.
Largest lesion < 4cm diameter
Must be a candidate for MRI imaging
Previous cranial stereotactic radiosurgery (SRS) or whole brain radiation therapy
(WBRT) is allowed if > 3 months prior to SIMT
Must be capable of providing informed consent
Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
Metastases within 2 mm of the optic apparatus
Patients unable to obtain MRI
Evidence of leptomeningeal disease
Greater than 10 brain metastases
Pregnant women are excluded
All locations for NCT02886572
United States (1)
Duke University Medical Center
Durham, North Carolina, United States, 27710
View full eligibility
Tris trial is registered with FDA with number: NCT02886572. The sponsor of the trial is Duke University and it is looking for 40 volunteers for the current phase.
Official trial title: Outcome in Patients With 4 or More Brain Metastases Treated With Single-Isocenter, Multi-Target (SIMT) Stereotactic Radiosurgery: A Prospective Single-arm Study in Adults With Brain Metastases
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