MIRA Clinical Learning Environment (MIRACLE): Lung

Trial Title: MIRA Clinical Learning Environment (MIRACLE): Lung

NCT ID: NCT05689437

Condition: Lung Cancer

Conditions: Keywords:
Machine Learning
Artificial Intelligence
Quality Improvement
Clinical Implementation

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Application of ILD prediction machine learning model to planning imaging
Description: The ILD prediction machine learning model will be applied to the treatment planning imaging of lung cancer patients receiving radiation therapy (RT). The model will score the risk as high risk or low risk for having underlying ILD.
Arm group label: ILD Prospective Mode
Arm group label: ILD Silent Mode

Intervention type: Other
Intervention name: Routine, automatic presentation of ILD risk level for evaluation by the clinician.
Description: Participating clinicians will be provided with an ILD risk estimate for all lung cancer patients receiving RT who are deemed potentially high-risk based on the model. In these cases, the clinician will receive an email identifying the patient medical record number (MRN) and 'potential high-risk for ILD' flag. Clinicians will then be able to decide whether, based on the information, they want to reassess the patient for ILD prior to starting treatment. Clinicians will also be presented with a short survey each time they are sent an email for a potential high-risk for ILD case so the study team can better understand how that information was used, if at all.
Arm group label: ILD Prospective Mode

Intervention type: Other
Intervention name: Application of SGR machine learning model to diagnostic and planning imaging
Description: The SGR machine learning model will be applied to the imaging of lung cancer patients with node negative lung cancer receiving stereotactic RT. The automatic calculation will compare target lesions on the patient's diagnostic images with those same lesions on treatment planning images.
Arm group label: SGR Prospective Mode
Arm group label: SGR Silent Mode

Intervention type: Other
Intervention name: Routine estimation of tumor specific growth rate (SGR) for lesions being considered for radiation therapy presented to clinician.
Description: Participating clinicians will be provided with an SGR calculation for each lung cancer patient with node negative lung cancer receiving stereotactic RT. This SGR calculation will be presented to clinicians, who will then be able to decide, based on the information, how they want to address and track a patient's overall survival and failure free survival. Clinicians will also be presented with a short survey each time they are provided with a patient's SGR calculation so the study team can better understand how that information was used, if at all.
Arm group label: SGR Prospective Mode

Intervention type: Other
Intervention name: Application of CBCT machine learning model to on-treatment imaging
Description: The CBCT machine learning model will be applied to on-treatment imaging as part of routine care for patients with node positive lung cancer receiving standard RT. An indicator of lung density changes will be calculated automatically by comparing cone beam CTs (CBCTs) completed prior to each treatment.
Arm group label: CBCT Prospective Mode
Arm group label: CBCT Silent Mode

Intervention type: Other
Intervention name: Routine monitoring of lung density changes during the course of treatment presented to clinician.
Description: Participating clinicians will be provided with a daily indicator of lung density changes for each patient with node positive lung cancer receiving standard RT. This measurement will be presented to the clinical team, who will then be able to decide, based on the information, how they want to address and track relevant outcomes such as pneumonitis. Additionally, this information may provide the clinical team with feedback about the lung reaction occurring as a result of treatment. Density changes will be documented and monitored for future validation studies, which are outside of the scope of this application.
Arm group label: CBCT Prospective Mode

Summary: The goal of this quality improvement (QI) study is to develop automated clinical pipelines to implement machine learning models in the care pathway of lung cancer patients. The main questions it aims to answer are: - Can model-prompted risk classifications be incorporated into clinician workflows to enable informed clinical decision-making? - What are clinicians' perceptions of the information from model outputs, and do they change their decision about data already available to them as a result of the model-prompted risk classification (i.e., to re-review or further assess patients identified by the models as being higher risk)? Participating radiation oncologists will receive the risk prediction from the model and be asked to complete a survey to give feedback on how they used the prediction in their decision-making.

Detailed description: Novel data science and imaging-based methods to personalize care are being identified retrospectively and explored at many centers. Unfortunately, most of these methods require significant manual intervention to apply to any given patient situation and are difficult to deploy in a timely fashion to affect patient treatment decisions. Clinical implementation of data science research will require automated pipelines that are tied into the entire treatment pathway in ways that facilitate real-time data analysis and enable translational research. The current process for clinical/translational researchers within Princess Margaret Hospital (PM)/University Health Network (UHN) to analyze imaging data involves extensive manual curation consisting of interactions with electronic databases and analysis tools to: identify patients with imaging data; collect that data; delineate targets of interest manually (minutes-to-hours per patient); analyze targets based on manually-selected images; and then correlate the analyzed images with clinical information sources (e.g. outcomes or correlative data). Thus, projects with large patient numbers often encounter insurmountable obstacles that limit research productivity. MIRA (an in-house developed programming toolkit) solves a common problem for all researchers at PM/UHN studying diagnostic, radiotherapy treatment planning, and/or on-treatment imaging by providing a consistent automated analysis environment for these data. MIRA also enhances ethics approved studies with direct linkage to real-time clinical data including diagnostic imaging via collaboration with the Joint Department of Medical Imaging, radiation oncology treatment planning information, and daily radiation oncology on-treatment imaging. The MIRA Clinical Learning Environment (MIRACLE) quality improvement project intends to use the MIRA platform to develop automated clinical pipelines to address three specific study aims: To identify lung cancer patients with undiagnosed underlying inflammatory lung disease (ILD) from pre-treatment diagnostic images To estimate individual patients' tumor growth-rate between diagnostic and treatment planning images (specific growth-rate, SGR) To provide each patient with an estimate of dynamic radiation treatment toxicity risk using radiation treatment planning information, while continuously updating risk estimates using daily cone-beam computed tomography (CBCT) images routinely obtained before each radiation treatment. MIRACLE is linked safely to active clinical data repositories and has the potential to directly impact daily cancer treatment decisions by making existing imaging data findable, rapidly accessible, interoperable, and reusable for both clinical and research analysis by end users including the physicians caring for lung cancer patients, and cancer researchers. This facilitates evaluation of novel imaging research findings in large patient numbers for clinical and research use. The MIRACLE project's goal is to specifically demonstrate the clinical implementation feasibility of automatically linking and analyzing clinical imaging data alongside clinical outcome; ultimately, helping to deliver value-based healthcare via better patient selection (ILD/SGR) and monitoring/adjusting treatment to decrease toxicity (CBCT). Feedback from the participating radiation oncologists will be gathered to assess the feasibility and effectiveness of showing patient-specific insights for inflammatory lung disease (ILD), a specific tumour growth rate greater than 0.04 (SGR) and cone-beam computed tomography system (CBCT) changes to clinicians at the point of care. The analysis will help to understand clinicians' perceptions of information provided to them from the model regarding ILD prediction, SGR and lung density changes over the QI period and whether clinicians changed their decision about data already available to them as a result of the model-prompted risk classification (i.e., to re-review or further assess patients for ILD, SGR and CBCT changes based on those patients highlighted by the model as being higher risk).

Criteria for eligibility:

Study pop:
All lung cancer patients 18 years or older receiving radiation therapy (RT) will be included in the study between 2000 until the end of the study. The type of RT received by the patient will further determine which of the three aims their data is suitable for, and therefore which clinical trial methodology will be used.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Diagnosed with lung cancer stage I-IV and planned for treatment with radiotherapy at Princess Margaret hospital. The three aims of this project have specific inclusion criteria as follows. - Aim 1 ILD: All lung cancer patients receiving RT. - Aim 2 SGR: Node negative lung cancer patients receiving stereotactic body RT. - Aim 3 CBCT: Node positive lung cancer patients receiving standard RT. Exclusion Criteria: - No exclusion criteria

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Princess Margaret Hospital

Address:
City: Toronto
Country: Canada

Status: Recruiting

Contact:
Last name: Andrew Hope, MD, FRCPC

Start date: January 1, 2022

Completion date: December 31, 2023

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Collaborator:
Agency: University of Toronto
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05689437
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf