Skåne University Hospital
Lund, Skåne County, 21185, Sweden
NCT Number: NCT05844761
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 is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Lund, Skåne County, 21185, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For prostate cancer patients:
For lung cancer patients:
Exclusion criteria
For prostate cancer patients:
For lung cancer patients:
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.
Time frame: At treatment completion, approximately 1-4 weeks
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
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 measured by kilovoltage imaging, including any prediction algorithms compared to without latency and other limitations compared with MAE.
Time frame: Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction..
EORTC guided and physician assessed
Time frame: At treatment completion, approximately 1-4 weeks
The percentage of fractions delivered without software or mechanical failure
Region Skane
Other
Acronym: REMIND
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04699188
Bronchial Neoplasms, Cancer of Lung
Atlanta, Georgia, United States
View Trial DetailsNCT04263467
Cancer, Cancer of Lung
Herlev, Denmark
View Trial DetailsNCT04300244
Adenoma, Cancer
Perth, Australia
View Trial DetailsNCT03102229
Cancer of Esophagus, Cancer of Lung
The Bronx, New York, United States
View Trial Details