LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology (LEARN)

August 22, 2023 updated by: University of Sydney

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

300

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

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
    • Queensland
    • Victoria
      • Melbourne, Victoria, Australia, 3000
      • Melbourne, Victoria, Australia, 3000

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University of Sydney

Collaborators

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

Investigators

  • Study Chair: Paul Keall, professor

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 Major Dates

Study Start (Estimated)

January 31, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IX-2021-DS-LEARN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After study completion.

IPD Sharing Access Criteria

Data stored at the university: In order to download / decompress the stored, de-identified data, participating researchers will agree to the terms of use for the data, including that the data are not to be published or otherwise redistributed without the express consent of the original investigator(s).

Data stored at an external repository: de-identified study data may be provided to an external research data repository, archive or register so that it may be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe