AI Screening for Lung Cancer

Not yet recruiting at 2 trial locations
MP
Overseen ByMary Pasquinelli, DNP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new AI tool called Sybil to determine if it predicts lung cancer risk more effectively than current methods. Researchers aim to discover whether using Sybil and expanding screening criteria can identify more individuals at risk for lung cancer. Participants will be divided into groups based on existing screening guidelines and will either receive a low-dose CT scan or be observed. The trial seeks individuals aged 50-80 with a history of significant smoking who are willing to watch a short educational video about the AI tool.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance future lung cancer screening methods.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Sybil AI tool is safe for lung cancer screening?

Research has shown that the Sybil AI tool effectively predicts lung cancer risk. Studies indicate that Sybil can accurately forecast future lung cancer risk using just one low-dose CT scan, helping identify individuals who might need more careful monitoring.

Importantly, Sybil itself poses no direct safety concerns because it is not a drug or physical treatment. As a tool that analyzes images and data to make predictions, it carries a very low risk of side effects.

The AI tool has demonstrated strong performance in predicting lung cancer risk with minimal bias, ensuring reliability and fairness in its assessments. While the AI itself doesn't pose safety risks, the study involves low-dose CT scans, which are generally safe and commonly used in medical settings.12345

Why are researchers excited about this trial?

Researchers are excited about the AI screening for lung cancer because it leverages cutting-edge technology to potentially enhance early detection. Unlike traditional methods like low-dose CT scans, this approach involves Sybil AI, which generates a personalized lung cancer risk score. This innovative technique could improve screening accuracy by identifying at-risk individuals who might not meet standard screening criteria, like those outlined by the United States Preventative Service Task Force. By refining risk assessment, this AI screening method promises to make lung cancer detection more precise and accessible.

What evidence suggests that the Sybil AI tool is effective for predicting lung cancer risk?

Research shows that Sybil, an artificial intelligence (AI) tool, can effectively predict the risk of lung cancer. Studies have found that Sybil accurately assesses a person's future lung cancer risk from just one low-dose CT scan. This AI model operates with little bias, making it a promising option for personalized screening. Sybil achieved a high accuracy score, with a 92% success rate for predicting lung cancer within 1 year and 75% within 6 years. In this trial, participants in Cohorts 1 and 2 will receive a low-dose CT scan and review their Sybil AI lung cancer risk score, while Cohort 3 will be observational with no Sybil score disclosure. These findings suggest that Sybil could be a valuable addition to lung cancer screening methods.12367

Who Is on the Research Team?

MP

Mary Pasquinelli, DNP

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-80 who are willing to learn about and possibly use the Sybil AI tool for lung cancer screening. They must be part of or scheduled for a Lung Screening Program, have a significant smoking history but no current or recent lung cancer, and not be pregnant. Participants should also meet certain smoking criteria based on USPSTF, Potter, or ACS guidelines.

Inclusion Criteria

Willing to view a short (approximately 2-minute) educational video that explains Sybil AI scoring and LCS, complete the Sybil AI survey (if selected), and/or provide blood samples (optional)
Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines
I am getting or will get a low-dose CT scan for lung screening at UI Health.
See 4 more

Exclusion Criteria

I was diagnosed with lung cancer less than 5 years ago.
Vulnerable population, including prisoners and pregnant or nursing women, will not be enrolled due to radiation exposure from LDCT, which is contraindicated in pregnancy
Other major comorbidity, as determined by the study PI
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a low-dose CT scan and view the Sybil AI video. They complete surveys and review their Sybil AI lung cancer risk score. Optional blood samples are collected.

Ongoing
1 visit (in-person)

Follow-up

Participants are monitored for lung cancer risk prediction performance and biomarker analysis.

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Sybil Artificial Intelligence (AI) screening

Trial Overview

The study tests if the Sybil AI can better predict lung cancer risk compared to current methods. It will assess expanding screening criteria beyond USPSTF guidelines using AI predictions and potentially integrate biomarkers from blood samples.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2Experimental Treatment1 Intervention
Group II: Cohort 1Experimental Treatment1 Intervention
Group III: Cohort 3Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Citations

Sybil AI Model Demonstrates Strong Performance in ...

According to the data presented, Sybil demonstrated minimal bias and strong performance in predicting 6-year lung cancer risk from baseline low- ...

Sybil: A Validated Deep Learning Model to Predict Future ...

Sybil can accurately predict an individual's future lung cancer risk from a single LDCT scan to further enable personalized screening.

Advancing Precision-Based Lung Cancer Screening ...

The study will investigate whether an artificial intelligence (AI) tool, known as Sybil, can aid in predicting the risk of lung cancer. The ...

Progress and challenges of artificial intelligence in lung ...

Sybil achieved area under the receiver-operator curves for lung cancer prediction at 1 year of 0.92 and 6 years of 0.75 on NLST. Such AI can be ...

Performance of Lung Cancer Prediction Models for ...

This study retrospectively evaluated promising predictive models for lung cancer prediction in three clinical settings: lung cancer screening with low-dose CT, ...

AI tools like Sybil poised to improve lung cancer screening ...

Improving lung cancer risk prediction. Risk models that identify candidates for screening based on factors beyond age and smoking history and ...

Comparing Artificial Intelligence and Traditional ...

AI-based models, particularly those using imaging data, show promise for improving lung cancer risk prediction over traditional regression models.