LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology

Breast Cancer Clinical Trial

— LEARN  

Official title:

LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05184790
• Other study ID #: IX-2021-DS-LEARN
• Status: Not yet recruiting
• Start date: January 31, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: August 2023
• Source: University of Sydney
• Contact: Shona Silvester
• Phone: +61 2 8627 1185
• Email: shona.silvester[@]sydney.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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'.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Australia	Alfred Health	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (6)

Lead Sponsor	Collaborator
University of Sydney	Austin Health, Calvary Mater Newcastle, Australia, Peter MacCallum Cancer Centre, Australia, Princess Alexandra Hospital, Brisbane, Australia, Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical acceptability of markerless tracking system	Proportion of radiation therapists considering the markerless tracking system acceptable using a survey	3 years