An observational study in Arrhythmias, Cardiac, Breast Cancer and Prostatic Cancer, sponsored by University of Sydney. Recruiting at 4 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by University of Sydney · Observational
This study will develop a whole-of-body markerless tracking method for measuring the motion of the tumour and surrounding organs during radiation therapy to enable real-time image guidance.
Routinely acquired patient data will be used to improve the training, testing and accuracy of a whole-of-body markerless tracking method. When the markerless tracking method is sufficiently advanced, according to the PI of each of the data collection sites, the markerless tracking method will be run in parallel to, but not intervening with, patient treatments during data acquisition.
This observational study will access routinely acquired radiation therapy treatment data from 300 patients including brain, breast, head and neck, kidney, liver, pancreas, prostate, spine and cardiac anatomic sites. At least 30 patients will be recruited from each anatomic site to enable sufficient data for the markerless tracking method training, testing and validation. The clinical data will be used to develop, train, test and validate a markerless target tracking method.
After the treatment, the ground truth and the variability in the ground truth will be computed. The patient images, the markerless tracking results, the ground truth and the variability will be uploaded to an in-house developed clinical trial learning system. Uploading additional data to the learning system automatically triggers the model building of the deep learning system. In this manner, the learning system gets both more accurate and more robust with each patient accrued. As the patient data accrues, the primary hypothesis of targeting accuracy can be tested.
The developed markerless tracking software will be applied by study personnel to the treatment imaging data for each anatomic site using five-fold cross-validation where 80% of the data is used for training and the remaining unseen 20% of the data is used for testing. Target positions produced by the markerless tracking will be compared with a 'ground truth'.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →University of Sydney is the lead sponsor of 94 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
300 participants, at least 30 from each of nine cohorts of anatomical sites receiving radiation therapy treatment.
Eight cohorts include: those being treated for cancer at anatomical sites of brain, head and neck, breast, liver, pancreas, kidney, prostate, spine; those being treated for cardiac arrhythmia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients having radiation therapy for treatment of brain cancer.
Patients having radiation therapy for treatment of breast cancer.
Patients having radiation therapy for treatment of head and neck cancer.
Patients having radiation therapy for treatment of kidney cancer.
Patients having radiation therapy for treatment of liver cancer.
Patients having radiation therapy for treatment of pancreatic cancer.
Patients having radiation therapy for treatment of prostate cancer.
Patients having radiation therapy for treatment of spinal cancer.
Patients having radiation therapy for treatment of cardiac arrhythmia
Accuracy of markerless tracking
Proportion of markerless tracking within 5 mm of the ground truth for each of nine anatomical sites (cohorts)
Time frame: 3 years
Clinical acceptability of markerless tracking system
Proportion of radiation therapists considering the markerless tracking system acceptable using a survey
Time frame: 3 years
Plan to share: Yes — After study completion, de-identified (non-coded, non-re-identifiable) data will be available to researchers for further scientific research. Information about data sharing will be provided to study participants in the Patient Information Sheet.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After study completion.
Access criteria: Data stored at the university: In order to download / decompress the stored, de-identified data, participating researchers will agree to the terms of use for the data, including that the data are not to be published or otherwise redistributed without the express consent of the original investigator(s). Data stored at an external repository: de-identified study data may be provided to an external research data repository, archive or register so that it may be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University.
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Jan 2028, 59 months after the start.
Of 189 non-industry observational studies under Arrhythmias, Cardiac, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 140. This study's planned 59 months is above that.
Counting every sponsor, half of 258 studies reached it within 38 months; a quarter within 16 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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University of Sydney