Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Prostatic Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients will undergo radiotherapy using the Triggered Imaging technique with TrueBeam for prostate cancer. The technology on the TrueBeam allows for monitoring and gating of the radiation beam in relation to the target position.

Patients will undergo radiotherapy using the Synchrony technique with Radixact for prostate cancer. Multi-Leaf Collimator Adaptation (MLC) and kilovoltage (kV) Intrafraction Monitoring with the Synchrony technique on the Radixact radiotherapy machine.

Patients will undergo radiotherapy using the Synchrony technique with Radixact for lung cancer. MLC Adaptation, Respiratory Motion Tracking, and kV Intrafraction Monitoring with the adaptive Synchrony technique on the Radixact radiotherapy machine.

At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique.

Triggered imaging on TrueBeam 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.

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 for lung cancer.

Synchrony MLC tracking and lung adaptive model with margin reduction

André Haraldsson, PhD, MPE

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.

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.

Patients will undergo radiotherapy using motion management techniques: Triggered Imaging with TrueBeam for prostate cancer, Synchrony with Radixact for prostate cancer, and Synchrony with Radixact for lung cancer. Dosimetric coverage will be assessed after treatment based on the accuracy of the motion management techniques and compared with dose coverage without motion management. After interim analysis, Planning target volume (PTV) will be reduced based on dosimetric accuracy in each arm.

Real-time Motion Management During Prostate and Lung Radiotherapy

The data used in this study contains sensitive information about the study participants and they did not provide consent for public data sharing. The current approval by the Swedish Ethical Review Authority does not include data sharing. A minimal data set could be shared by request from a qualified academic investigator for the sole purpose of replicating the present study, provided the data transfer is in agreement with European Union legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority.

Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.

The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape based on the centroid of the shape as assessed with mean absolute error (MAE)

Motion trajectory measured by kilovoltage imaging, including any prediction algorithms compared to without latency and other limitations compared with MAE.

The percentage of fractions delivered without software or mechanical failure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Real-time Motion Management During Prostate and Lung Radiotherapy	NCT05844761	Cancer of Lung Lung Metastasis Cancer of Prost...	Triggered imagi... Synchrony MLC t... Synchrony MLC t...	18 Years -	Region Skane
Real-time Motion Management During Prostate and Lung Radiotherapy	NCT05844761	Cancer of Lung Lung Metastasis Cancer of Prost...	Triggered imagi... Synchrony MLC t... Synchrony MLC t...	18 Years -	Region Skane

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