Arrhythmias, CardiacLEARNNCT05184790
LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
An observational study of Arrhythmias, Cardiac and Breast Cancer, run by University of Sydney at 4 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac, Breast Cancer, Prostatic Cancer
- How many people
- 300 participants
- Where
- 4 sitesAustralia
- Study dates
- 28 Feb 2023to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Will receive radiation therapy for brain, breast, head and neck, kidney, liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment at a participating centre.
- Will receive CT planning, and a cone beam CT scan for at least one fraction of radiation therapy.
- Will receive intrafraction x-ray imaging for the liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment. As intrafraction imaging is not common standard of care for brain, breast, head and neck and kidney cancer treatments there is no requirement to have intrafraction x-ray imaging data for these anatomical sites.
- Provides written informed consent.
Who cannot join
- Less than 18 years of age
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites, 4 recruiting
- Not yet recruiting
Alfred Health
Melbourne, Victoria, 3000
Principal Investigator, s.senthi@alfred.org.au
- Not yet recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Principal Investigator, shankar.siva@petermac.org
- Recruiting
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Principal Investigator, thomas.eade@health.nsw.gov.au
- Not yet recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Principal Investigator, yooyoung.lee@health.qld.gov.au
About this study
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.
Read the detailed description
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'.
- Conditions
- Arrhythmias, Cardiac, Breast Cancer, Prostatic Cancer, Brain Cancer, Kidney Cancer, Head and Neck Cancer
- Keywords
- Radiation Therapy, markerless tracking
- Medical subject headings
- Arrhythmias, Cardiac, Breast Neoplasms, Prostatic Neoplasms, Brain Neoplasms, Kidney Neoplasms, Head and Neck Neoplasms, Liver Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Brain cancer | Patients having radiation therapy for treatment of brain cancer. | |
| Breast cancer | Patients having radiation therapy for treatment of breast cancer. | |
| Head and neck cancer | Patients having radiation therapy for treatment of head and neck cancer. | |
| Kidney cancer | Patients having radiation therapy for treatment of kidney cancer. | |
| Liver cancer | Patients having radiation therapy for treatment of liver cancer. | |
| Pancreatic cancer | Patients having radiation therapy for treatment of pancreatic cancer. | |
| Prostatic cancer | Patients having radiation therapy for treatment of prostate cancer. | |
| Spinal neoplasm | Patients having radiation therapy for treatment of spinal cancer. | |
| Cardiac arrhythmia | Patients having radiation therapy for treatment of cardiac arrhythmia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of markerless tracking
Proportion of markerless tracking within 5 mm of the ground truth for each of nine anatomical sites (cohorts)
Measured: 3 years
Secondary outcomes (1)
Clinical acceptability of markerless tracking system
Proportion of radiation therapists considering the markerless tracking system acceptable using a survey
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start28 Feb 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Alexandra Hospital, Brisbane, Australia, Calvary Mater Newcastle, Australia, Western Sydney Local Health District, Austin Health, Peter MacCallum Cancer Centre, Australia
- Responsible party
- Sponsor
- Investigators
- Paul Keall, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184790
- Sponsor's protocol ID
- IX-2021-DS-LEARN
- Acronym
- LEARN
- Status last verified
- May 2026
- First submitted
- 22 Dec 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
- ClinicalTrials.gov ID
- NCT05184790
- Acronym / sponsor ID
- LEARN / IX-2021-DS-LEARN
- Conditions
- Arrhythmias, Cardiac, Breast Cancer, Prostatic Cancer, Brain Cancer, Kidney Cancer, Head and Neck Cancer
- Keywords
- Radiation Therapy, markerless tracking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Princess Alexandra Hospital, Brisbane, Australia, Calvary Mater Newcastle, Australia, Western Sydney Local Health District, Austin Health, Peter MacCallum Cancer Centre, Australia
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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'.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Brain cancer | – | –Patients having radiation therapy for treatment of brain cancer. |
| Breast cancer | – | –Patients having radiation therapy for treatment of breast cancer. |
| Head and neck cancer | – | –Patients having radiation therapy for treatment of head and neck cancer. |
| Kidney cancer | – | –Patients having radiation therapy for treatment of kidney cancer. |
| Liver cancer | – | –Patients having radiation therapy for treatment of liver cancer. |
| Pancreatic cancer | – | –Patients having radiation therapy for treatment of pancreatic cancer. |
| Prostatic cancer | – | –Patients having radiation therapy for treatment of prostate cancer. |
| Spinal neoplasm | – | –Patients having radiation therapy for treatment of spinal cancer. |
| Cardiac arrhythmia | – | –Patients having radiation therapy for treatment of cardiac arrhythmia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Will receive radiation therapy for brain, breast, head and neck, kidney, liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment at a participating centre.
- Will receive CT planning, and a cone beam CT scan for at least one fraction of radiation therapy.
- Will receive intrafraction x-ray imaging for the liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment. As intrafraction imaging is not common standard of care for brain, breast, head and neck and kidney cancer treatments there is no requirement to have intrafraction x-ray imaging data for these anatomical sites.
- Provides written informed consent.
Key exclusion criteria (1 listed)
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of markerless tracking
Time frame: 3 years
Proportion of markerless tracking within 5 mm of the ground truth for each of nine anatomical sites (cohorts)
1 secondary outcome
Clinical acceptability of markerless tracking system
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Keall study chair
Professor
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac and Breast Cancer, run by University of Sydney at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shona Silvester (+61 2 8627 1185, shona.silvester@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of markerless tracking (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.