LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology

NCT ID: NCT05184790

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-28

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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'.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brain cancer

Patients having radiation therapy for treatment of brain cancer.

No interventions assigned to this group

Breast cancer

Patients having radiation therapy for treatment of breast cancer.

No interventions assigned to this group

Head and neck cancer

Patients having radiation therapy for treatment of head and neck cancer.

No interventions assigned to this group

Kidney cancer

Patients having radiation therapy for treatment of kidney cancer.

No interventions assigned to this group

Liver cancer

Patients having radiation therapy for treatment of liver cancer.

No interventions assigned to this group

Pancreatic cancer

Patients having radiation therapy for treatment of pancreatic cancer.

No interventions assigned to this group

Prostatic cancer

Patients having radiation therapy for treatment of prostate cancer.

No interventions assigned to this group

Spinal neoplasm

Patients having radiation therapy for treatment of spinal cancer.

No interventions assigned to this group

Cardiac arrhythmia

Patients having radiation therapy for treatment of cardiac arrhythmia

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Princess Alexandra Hospital, Brisbane, Australia

OTHER

Sponsor Role collaborator

Calvary Mater Newcastle, Australia

OTHER

Sponsor Role collaborator

Western Sydney Local Health District

OTHER

Sponsor Role collaborator

Austin Health

OTHER_GOV

Sponsor Role collaborator

Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Keall

Role: STUDY_CHAIR

Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status NOT_YET_RECRUITING

Alfred Health

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shona Silvester

Role: CONTACT

+61 2 8627 1185

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IX-2021-DS-LEARN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pelvis Adaptive Radiotherapy (ART)
NCT06650033 NOT_YET_RECRUITING NA