LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology

NCT05184790 | Recruiting

• 1 other identifier: IX-2021-DS-LEARN
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical acceptability of markerless tracking system

  3 years

Study Arms (9)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Less than 18 years of age

Sponsors & Collaborators

• University of Sydney: lead
• Princess Alexandra Hospital, Brisbane, Australia: collaborator
• Calvary Mater Newcastle, Australia: collaborator
• Western Sydney Local Health District: collaborator
• Austin Health: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator

Study Sites (4)

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

NOT YET RECRUITING

Alfred Health

Melbourne, Victoria, 3000, Australia

NOT YET RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Breast Neoplasms; Prostatic Neoplasms; Brain Neoplasms; Kidney Neoplasms; Head and Neck Neoplasms; Liver Neoplasms; Pancreatic Neoplasms; Spinal Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Study Officials

• Paul Keall

  Professor

  STUDY CHAIR

Central Study Contacts

Shona Silvester

CONTACT

+61 2 8627 1185; shona.silvester@sydney.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: February 28, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study completion.
• 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.

Locations

AU (4)