Chest CT Scan for Lung Cancer

(IDEAL Trial)

Overseen By Crista L Bartolomeu, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Disqualifiers: Pregnancy, Recent respiratory infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

3600 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this trial is to (a) identify people at high risk of lung cancer who would benefit from LDCT screening but are currently ineligible based on current lung cancer screening criteria (b) provide the framework to manage patients with Incidental Pulmonary Nodules (IPNs) with appropriate follow-up based on accurate interpretation of the Chest CT scan that is already available and (c) develop a simple, point-of-care, minimally invasive test, focusing on the breath and circulating blood proteins, to detect lung cancer, and develop a method to differentiate between cancerous and non-cancerous nodules using a single. Participants will be asked to answer a questionnaire regarding their age, race/ethnicity, smoking history, and residential history if they have ever been told they have chronic obstructive pulmonary disease (COPD), high blood pressure, education level, medications and height and weight. Participants will then be asked to give a breath sample via the breath collection device. All this information will be collected before the breath collection. After that, participants will give 1-2 tablespoons of blood. CT scans with IPN(s) will be reviewed and run through a computer detection software to identify nodules, followed up as per current clinical guidelines.

Research Team

Rayjean Hung, PhD

Principal Investigator

Sinai Health

Renelle L Myers, MD

Principal Investigator

VCH, UBC

Eligibility Criteria

The IDEAL Study is for people at high risk of lung cancer who don't currently qualify for low-dose CT (LDCT) screening. It's also for those with Incidental Pulmonary Nodules (IPNs). Participants should be willing to provide detailed personal health information, a breath sample, and a small blood sample.

Inclusion Criteria

Chest CT positive for nodule equal to or greater than 6mm

Able to consent

I can avoid smoking for 24 hours before the breath test.

Exclusion Criteria

Unwilling to consent to the study

Too sick to provide a breath sample

Smoked in the last 24 hours

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Breath and Blood Sample Collection

Participants provide a breath sample and 1-2 tablespoons of blood for analysis

1 day

1 visit (in-person)

CT Scan Review and Follow-up

CT scans with IPNs are reviewed and followed up as per current clinical guidelines

4 years

Follow-up

Participants are monitored for safety and effectiveness after initial assessments

4 years

Treatment Details

Interventions

• Chest CT Scan

Trial Overview This study tests methods to improve early lung cancer detection in diverse populations. It evaluates the use of Chest CT scans to manage IPNs and develops new tests using breath and blood samples to distinguish between cancerous and non-cancerous nodules.

Participant Groups

Group I: Incidental Pulmonary Nodule Arm Experimental Treatment 1 Intervention

Nodule Follow up as per Fleischner Guidelines

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Lunenfeld Tanenbaum Research Institute

Collaborator

Trials

4

Recruited

5,000+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Lunenfeld Tanenbaum Research Institute

Collaborator

Trials

4

Recruited

5,000+