Cyberknife System for Sterotactic Radiosurgery Radiotherapy

FDA-Cleared Indications

• Delivery of stereotactic radiosurgery or radiotherapy using a computer-controlled linear accelerator and image guidance.
• Treatment of selected tumors or lesions for which highly conformal, precisely targeted radiation is clinically appropriate.
• Noninvasive radiation treatment when the target can be localized and monitored with the system's imaging and tracking capabilities.

Clinical Applications

• Image-guided stereotactic radiosurgery for selected intracranial tumors or lesions.
• Stereotactic body radiotherapy for selected extracranial tumors or lesions.
• Radiation treatment of selected tumors in the spine, lung, liver, pancreas, or prostate when the treatment plan meets system and clinical requirements.
• Treatment of patients who are not suitable for conventional surgery or who require a noninvasive, highly targeted radiation approach.

Reported off-label uses

• Selected reirradiation treatments when a radiation oncology team determines that the expected benefit outweighs the risks.
• Selected functional or vascular intracranial targets, such as arteriovenous malformations, depending on the treatment plan and applicable regulatory and institutional requirements.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• Treatment requires simulation, immobilization, three-dimensional imaging, target delineation, dose planning, and verification before radiation is delivered.
• The robotic arm and image-guidance system can deliver radiation from multiple angles and compensate for some measured patient or target movement; accurate positioning remains essential.
• The system is not an implanted device and is not itself an MRI scanner. MRI may be used for planning when clinically appropriate, but MRI safety depends on the patient's implants and the specific imaging protocol.
• Treatment may be delivered in one session or several fractions depending on tumor size, location, nearby organs, prior radiation, and the radiation oncologist's plan.
• Contraindications and limitations can include inability to remain positioned, inability to obtain adequate target imaging, excessive target motion, and treatment plans that would exceed safe doses to nearby organs.