LEARN: Learning Environment For Artificial Intelligence In Radiotherapy New Technology

Study Overview

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.

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'.

Arrhythmias, Cardiac
Breast Cancer
Prostatic Cancer
Brain Cancer
Kidney Cancer
Head and Neck Cancer
Liver Cancer
Pancreatic Cancer
Spinal Neoplasm

IX-2021-DS-LEARN

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-12-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-24
First Submitted that Met QC Criteria 2022-01-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-26
First Posted (ACTUAL) 2022-01-11	Results First Posted N/A	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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

Primary Outcome Measures	Measure Description	Time Frame
Accuracy of markerless tracking	Proportion of markerless tracking within 5 mm of the ground truth for each of nine anatomical sites (cohorts)	3 years

Secondary Outcome Measures	Measure Description	Time Frame
Clinical acceptability of markerless tracking system	Proportion of radiation therapists considering the markerless tracking system acceptable using a survey	3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shona Silvester

Phone Number: +61 2 8627 1185

Email: shona.silvester@sydney.edu.au

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Less than 18 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

STUDY_CHAIR: Paul Keall, Professor

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record