An interventional study of Triggered imaging on TrueBeam with margin reduction and Synchrony MLC tracking on fiducials with margin reduction in Cancer of Lung, Lung Metastasis and Cancer of Prostate, sponsored by Region Skane. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
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:
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 132 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For prostate cancer patients:
For lung cancer patients:
Exclusion Criteria:
For prostate cancer patients:
For lung cancer patients:
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.
Radiation: Triggered imaging on TrueBeam with margin reduction
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.
Radiation: Synchrony MLC tracking on fiducials with margin reduction
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.
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 TrueBeam triggered imaging motion management technique.
At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique.
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.
Dosemetric accuracy
Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.
Time frame: At treatment completion, approximately 1-4 weeks
Geometric accuracy
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)
Time frame: At treatment completion, approximately 1-4 weeks
Motion trajectory
Motion trajectory measured by kilovoltage imaging, including any prediction algorithms compared to without latency and other limitations compared with MAE.
Time frame: At treatment completion, approximately 1-4 weeks
Acute Toxicity
EORTC guided and physician assessed
Time frame: Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction..
Mechanical & software failure
The percentage of fractions delivered without software or mechanical failure
Time frame: At treatment completion, approximately 1-4 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Region Skane