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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to screen for lung cancer and manage lung nodules (small growths in the lung). Researchers seek to identify high-risk individuals who might benefit from a special type of CT scan (chest CT scan) but aren't currently eligible. They are also developing a simple test using breath and blood samples to detect cancer and determine if lung nodules are cancerous. The study seeks participants with a lung nodule of at least 6mm, who haven't smoked in the last 24 hours, and can provide a breath sample. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve early detection and management of lung cancer.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but you should confirm with the trial organizers.

What prior data suggests that this method is safe for lung cancer screening?

Research has shown that chest CT scans are safe for detecting lung issues. These scans often reveal small growths in the lungs called pulmonary nodules, with more than 95% being non-cancerous and usually not harmful.

Chest CT scans are non-invasive, similar to an X-ray, and do not require surgery. They use a small amount of radiation to capture images of the lungs, and this radiation level is generally considered safe. Doctors adhere to guidelines to monitor any nodules found, ensuring proper management.

Overall, chest CT scans are well-tolerated and have a strong safety record in patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using chest CT scans for lung cancer detection because they provide detailed images that can spot small nodules in the lungs, which might go unnoticed with traditional X-rays. Unlike other methods that might require invasive procedures for a clear diagnosis, CT scans are non-invasive and offer a faster, more comfortable experience for patients. This approach could lead to earlier detection and treatment of lung cancer, potentially improving outcomes and survival rates.

What evidence suggests that a Chest CT Scan is effective for identifying lung cancer?

Studies have shown that chest CT scans effectively detect early-stage lung cancer. Research indicates that a computerized system for tracking lung nodules can increase the detection of stage 1 non-small cell lung cancer (NSCLC) when examining unexpected lung nodules. One study found that even with a very low-dose CT scan, the nodule detection rate remained high at 84.6%. This suggests that chest CT scans are a powerful tool for early lung cancer detection, which is crucial for better outcomes. Although not all nodules are cancerous, these scans assist doctors in determining the best next steps. Participants in this trial will join the Incidental Pulmonary Nodule Arm, where nodule follow-up will adhere to Fleischner Guidelines. ^{6 7 8 9 10}

Who Is on the Research Team?

Renelle L Myers, MD

Principal Investigator

VCH, UBC

Rayjean Hung, PhD

Principal Investigator

Sinai Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12248454/

Management and Outcomes of Pulmonary Nodules in a ... CT-guided biopsy was performed in 10 patients as first step. In 60% (6/10), histology revealed lung cancer, and in 40% (4/10), benign results ...

2. journal.chestnet.org journal.chestnet.org/article/S0012-3692(25)00281-8/fulltext

Interventions to Improve Adherence to Clinical Guidelines for ... Lung cancer survival has only modestly improved over time, and long-term survival remains poor (10% 10-year survival rate) with a key driver of ...

3. nature.com nature.com/articles/s41591-024-03211-3

Data-driven risk stratification and precision management of ... For instance, only 3.6% of detected lung nodules were diagnosed as malignant in the NLST, and the baseline false-positive rate (FPR) was as high ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666364322000212

Improvement in Stage of Lung Cancer Diagnosis With ... The application of a patient tracking system and computerized lung nodule registry lead to an increased frequency in the diagnosis of stage 1 NSCLC from IPNs.

5. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-024-01888-1

Ultra-low dose dual-layer detector spectral CT for ... These results were confirmed by quantitative image quality analysis with a favorable nodule detection rate of 84.6% for EDM at ultra-low dose CT ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12094709/

Incidental Pulmonary Nodules: Differential Diagnosis and ... More than 95% of all pulmonary nodules revealed by computerized tomography (CT) are benign, but many cases are not managed in conformity with the guidelines. In ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369221000337

Creating an Incidental Pulmonary Nodule Safety-Net ... Incidental pulmonary nodules on CT scans have been reported in 2.5% to 8.4% of abdominal CT scans,4, 5, 6, 7, 8 in 10% to 30% of chest CT scans,9, 10, 11, 12, ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2785262

Pulmonary Nodules | Cancer Screening, Prevention, Control Approximately 50% of patients who undergo CT screening for lung cancer are found to have a pulmonary nodule. Approximately 95% of pulmonary ...

9. journal.chestnet.org journal.chestnet.org/article/S0012-3692(24)03207-0/fulltext

INCIDENTAL LUNG NODULE PROGRAM: A NEW ... Our ILN program serves as a vital healthcare safety net, detecting and monitoring potentially malignant nodules.

10. aafp.org aafp.org/pubs/afp/issues/2023/0300/pulmonary-nodules.html

Pulmonary Nodules: Common Questions and Answers The incidence of pulmonary nodules in lung cancer screening programs has been reported at approximately 27%, with 1.1% of patients diagnosed with lung cancer.