LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology (LEARN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05184790 |
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Recruitment Status :
Not yet recruiting
First Posted : January 11, 2022
Last Update Posted : August 23, 2023
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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.
| Condition or disease |
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| Arrhythmias, Cardiac Breast Cancer Prostatic Cancer Brain Cancer Kidney Cancer Head and Neck Cancer Liver Cancer Pancreatic Cancer Spinal Neoplasm |
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 |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology |
| Estimated Study Start Date : | January 31, 2024 |
| Estimated Primary Completion Date : | January 31, 2026 |
| Estimated Study Completion Date : | January 31, 2026 |
| Group/Cohort |
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Brain cancer
Patients having radiation therapy for treatment of brain cancer.
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Breast cancer
Patients having radiation therapy for treatment of breast cancer.
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Head and neck cancer
Patients having radiation therapy for treatment of head and neck cancer.
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Kidney cancer
Patients having radiation therapy for treatment of kidney cancer.
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Liver cancer
Patients having radiation therapy for treatment of liver cancer.
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Pancreatic cancer
Patients having radiation therapy for treatment of pancreatic cancer.
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Prostatic cancer
Patients having radiation therapy for treatment of prostate cancer.
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Spinal neoplasm
Patients having radiation therapy for treatment of spinal cancer.
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Cardiac arrhythmia
Patients having radiation therapy for treatment of cardiac arrhythmia
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- 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)
- Clinical acceptability of markerless tracking system [ Time Frame: 3 years ]Proportion of radiation therapists considering the markerless tracking system acceptable using a survey
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05184790
| Contact: Shona Silvester | +61 2 8627 1185 | shona.silvester@sydney.edu.au | |
| Contact: Natalie Plant | natalie.plant@sydney.edu.au |
| Australia, New South Wales | |
| Royal North Shore Hospital | |
| Saint Leonards, New South Wales, Australia, 2065 | |
| Contact: Principal Investigator thomas.eade@health.nsw.gov.au | |
| Australia, Queensland | |
| Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Contact: Principal Investigator yooyoung.lee@health.qld.gov.au | |
| Australia, Victoria | |
| Alfred Health | |
| Melbourne, Victoria, Australia, 3000 | |
| Contact: Principal Investigator s.senthi@alfred.org.au | |
| Peter MacCallum Cancer Centre | |
| Melbourne, Victoria, Australia, 3000 | |
| Contact: Principal Investigator shankar.siva@petermac.org | |
| Study Chair: | Paul Keall | Professor |
| Responsible Party: | University of Sydney |
| ClinicalTrials.gov Identifier: | NCT05184790 |
| Other Study ID Numbers: |
IX-2021-DS-LEARN |
| First Posted: | January 11, 2022 Key Record Dates |
| Last Update Posted: | August 23, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Radiation Therapy markerless tracking |
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Kidney Neoplasms Brain Neoplasms Prostatic Neoplasms Spinal Neoplasms Arrhythmias, Cardiac Neoplasms by Site Neoplasms Heart Diseases Cardiovascular Diseases Pathologic Processes Urologic Neoplasms Urogenital Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Kidney Diseases Urologic Diseases Male Urogenital Diseases Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Genital Neoplasms, Male Genital Diseases, Male Genital Diseases Prostatic Diseases Bone Neoplasms Bone Diseases Musculoskeletal Diseases |