LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology

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.

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Key information

Conditions

Arrhythmias, Cardiac Bone Diseases Bone Neoplasms Brain Cancer Brain Diseases Brain Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Heart Diseases Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Male Urogenital Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Spinal Diseases Spinal Neoplasm Spinal Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal North Shore Hospital, Saint Leonards, New South Wales, Australia

About this study

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'.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Less than 18 years of age

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

Clinical acceptability of markerless tracking system

Time frame: 3 years

Proportion of radiation therapists considering the markerless tracking system acceptable using a survey

Study contacts

Contact information is provided by the study sponsor or research team.

Shona Silvester

CONTACT

[email protected]

+61 2 8627 1185

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

Austin Health
Calvary Mater Newcastle, Australia
Peter MacCallum Cancer Centre, Australia
Princess Alexandra Hospital, Brisbane, Australia
Western Sydney Local Health District

Registry information

Acronym: LEARN

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Jan 11, 2022
Registry last updated: May 19, 2026

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.

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Recruiting