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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05184790
Registration number
NCT05184790
Ethics application status
Date submitted
22/12/2021
Date registered
11/01/2022
Date last updated
23/08/2023
Titles & IDs
Public title
LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
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Scientific title
LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
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Secondary ID [1]
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IX-2021-DS-LEARN
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Universal Trial Number (UTN)
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Trial acronym
LEARN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arrhythmias, Cardiac
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Breast Cancer
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Prostatic Cancer
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Brain Cancer
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Kidney Cancer
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Head and Neck Cancer
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Liver Cancer
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Pancreatic Cancer
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Spinal Neoplasm
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Condition category
Condition code
Cancer
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Kidney
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Cancer
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Brain
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Cancer
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Prostate
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Musculoskeletal
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Other muscular and skeletal disorders
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Accuracy of markerless tracking
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Assessment method [1]
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Proportion of markerless tracking within 5 mm of the ground truth for each of nine anatomical sites (cohorts)
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Clinical acceptability of markerless tracking system
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Assessment method [1]
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Proportion of radiation therapists considering the markerless tracking system acceptable using a survey
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Timepoint [1]
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3 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Less than 18 years of age
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
31/01/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/01/2026
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
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Alfred Health - Melbourne
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Princess Alexandra Hospital, Brisbane, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Calvary Mater Newcastle, Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Western Sydney Local Health District
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Austin Health
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Peter MacCallum Cancer Centre, Australia
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05184790
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Keall
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Address
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Professor
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Shona Silvester
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Address
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Country
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Phone
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+61 2 8627 1185
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05184790
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