Clinical trial NCT05184790: LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
Official title: LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmias, Cardiac
Breast Cancer
Prostatic Cancer
Brain Cancer
Kidney Cancer
Head and Neck Cancer
Liver Cancer
Pancreatic Cancer
Spinal Neoplasm
Keywords: Radiation Therapy
markerless tracking
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Princess Alexandra Hospital, Brisbane, Australia
name: Calvary Mater Newcastle, Australia
name: Western Sydney Local Health District
name: Austin Health
name: Peter MacCallum Cancer Centre, Australia
First posted: 2022-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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'.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of markerless tracking
timeFrame: 3 years
Secondary outcomes:
measure: Clinical acceptability of markerless tracking system
timeFrame: 3 years
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Professor
name: Paul Keall
role: STUDY_CHAIR
References: