NCT06309810

Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia

Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia: a Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity. The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year.

Conditions

• Spasticity/Paresis

Interventions

Type	Name	Description
RADIATION	Radiotherapy	The treatment will be administered with a TrueBeam™ (Varian Medical Systems, Palo Alto, CA, USA) linac, equipped with a Millenium 120-leaves MLC. The target will be represented by 5 mm of the specific spinal nerve responsible for the spams. A lateral 1 mm margin will be added to the target to generate the corresponding planning treatment volume (PTV). The prescribed dose will be 45-60 Gy in a single fraction. The treatment dose will be chosen based on patients' general condition, and possibility to respect the dose limits (constraints) for the organs at risk (OARs).

Timeline

• Start date: 2023-03-06
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: Italy