NCT05844761

Real-time Motion Management During Prostate and Lung Radiotherapy

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional non-inferiority trial is to assess the accuracy of different real-time motion management radiotherapy techniques. The main question the study aims to answer are: * What are the target margins for radiotherapy with motion management that are not inferior to target margin without motion management * What are the dosimetric and geometrical accuracy to patient for the motion management techniques. Participants will answer QoL questionary, and the accuracy of treatment will be assessed from treatment data.

Detailed description

This study will assess the feasibility of implementing real-time tracking in a clinical setting to account for the relative motion of the moving tumours localised to the prostate or lung. The capability to track the treatment target's motion will ensure that the dose prescribed by the radiation oncologist is the dose delivered to the target and minimises side effects to the critical organs. During radiation treatment, the target position will be monitored in real-time using built-in imaging technology. The radiation beam shape will be altered to compensate for the moved target positions by the treatment delivery system. The delivered dose to the patient will be calculated after the treatment and compared to the dose without real-time tracking to assess the potential benefit to treatment efficacy, recognising that the radiation dose received by tumour tissue is a very strong biomarker for response. The estimated dose distributions will be compared to the original plan for non-inferiority using the dose reconstruction method based on the prostate motion trajectory and the logged MLC positions (beam shapes). Also, the impact on organs at risk doses due to MLC target tracking.

Conditions

• Cancer of Lung
• Lung Metastasis
• Cancer of Prostate

Interventions

Type	Name	Description
RADIATION	Triggered imaging on TrueBeam with margin reduction	At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique.
RADIATION	Synchrony MLC tracking on fiducials with margin reduction	At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique.
RADIATION	Synchrony MLC tracking and lung adaptive model with margin reduction	At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique for lung cancer.

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2023-05-06
• Last updated: 2025-05-21

Locations

1 site across 1 country: Sweden