LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology

Sponsor

University of Sydney (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05184790

Collaborator

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

300

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmias, Cardiac Breast Cancer Prostatic Cancer Brain Cancer Kidney Cancer Head and Neck Cancer Liver Cancer Pancreatic Cancer Spinal Neoplasm

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

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology

Anticipated Study Start Date :

Jan 31, 2022

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Accuracy of markerless tracking [3 years]
Proportion of markerless tracking within 5 mm of the ground truth for each of nine anatomical sites (cohorts)

Secondary Outcome Measures

Clinical acceptability of markerless tracking system [3 years]
Proportion of radiation therapists considering the markerless tracking system acceptable using a survey

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal North Shore Hospital	Saint Leonards	New South Wales	Australia	2065
2	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
3	Alfred Health	Melbourne	Victoria	Australia	3000
4	Peter MacCallum Cancer Centre	Melbourne	Victoria	Australia	3000