Low-dose CT for Lung Cancer

Overseen By Ali Nowroozi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Recent malignancy, Pregnancy, Recent CT, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the prevalence of lung cancer and related lung diseases in firefighters. Due to exposure to harmful substances, firefighters face higher cancer risks. The study uses low-dose chest CT scans (low-dose computerized tomography) to detect these conditions. The trial includes two groups: firefighters who have never had cancer or had it more than five years ago, and those with a history of chest cancer. Participants must have served as firefighters for at least 10 years and either quit smoking over 15 years ago or never smoked. As an unphased trial, this study allows participants to contribute to important research that could improve health outcomes for firefighters.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that low-dose CT is safe for lung cancer screening in firefighters?

Studies have shown that low-dose computed tomography (LDCT) scans are generally safe for lung cancer screening. Many health organizations recommend LDCT for adults with a history of heavy smoking, as it can detect lung cancer early. Early detection can lead to better outcomes and even save lives.

Research indicates that LDCT scans use less radiation than regular CT scans, reducing the risk of radiation harm. Most individuals tolerate these scans well, with few reports of side effects. Although any procedure carries some risk, LDCT is considered a safe screening option, particularly for those at high risk of lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using low-dose CT scans for lung cancer screening, particularly in high-risk groups like firefighters, because it offers a safer and potentially more effective way to detect cancer early. Unlike standard chest X-rays, low-dose CT scans provide more detailed images, which can help identify smaller tumors at an earlier stage when they're more treatable. This method uses significantly less radiation than traditional CT scans, making it a safer option for regular screening. By utilizing this advanced imaging technology, the goal is to improve early detection rates and outcomes for individuals at high risk of lung cancer.

What evidence suggests that low-dose CT is effective for lung cancer screening in firefighters?

Research has shown that low-dose CT scans can detect lung cancer early. The National Lung Screening Trial found a 20% reduction in lung cancer deaths when using low-dose CT scans instead of regular chest X-rays. Early results also indicate that these scans are more effective at detecting lung cancer in non-smokers with a family history of the disease. This screening method can accurately differentiate between cancerous and non-cancerous growths 87% of the time. In this trial, one group of participants, specifically firefighters, will receive a single, low-dose chest CT for lung cancer screening. These findings support the use of low-dose CT scans to detect lung cancer in high-risk groups, such as firefighters. ^{4 6 7 8 9}

Who Is on the Research Team?

Jae Ho Sohn, MD, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for firefighters who may have been exposed to substances that can cause cancer. It's designed to see if they have lung cancer or other diseases from their job, even if they haven't smoked much or at all.

Inclusion Criteria

Never smoker or quit more than 15 years ago.

I understand and can follow the study's procedures.

Length in profession for 10 or more years. This includes both volunteer firefighting and professional firefighting, self-attested as verifiable by professional records.

Exclusion Criteria

For Aim 1: Participants will be assessed for active pregnancy per standard procedure for clinical lung cancer screening CT at University of California, San Francisco which includes asking the participants directly along with documentation of whether the negative pregnancy was self-reported or confirmed with a urine pregnancy test.

For Aim 1: Prior CT chest within 1 year.

For Aim 1: Contraindication to any study-related procedure or assessment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants receive a single, low-dose chest CT scan and comprehensive data collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial CT scan, with follow-up imaging and biopsy results collected if applicable

1-2 months

1 visit (in-person or virtual)

Long-term Follow-up

Participants are followed up for at least 1 year and up to 10 years to monitor the incidence of lung cancer and other cancers

1-10 years

What Are the Treatments Tested in This Trial?

Interventions

• Low-dose Computerized tomography (CT) of Chest

Trial Overview The study involves giving firefighters chest CT scans and having them fill out questionnaires about their health and work history. The goal is to find out how common lung cancer and related diseases are in this high-risk group.

How Is the Trial Designed?

Group I: Firefighters with Previously Diagnosed Malignancy Experimental Treatment 1 Intervention

Participants with a history of cancer will have a medical record review as part of a case-control cohort.

Group II: Firefighters (Lung Screening CT) Experimental Treatment 3 Interventions

Participants will receive a single, low-dose, chest CT without contrast as indicated for lung cancer screening. Participants will be followed up for at least 1 year following the scan and have ongoing medical record reviews.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Hayward Firefighters Local 1909 of the International Association of Firefighters

Collaborator

Trials

1

Recruited

1,200+

Published Research Related to This Trial

Nearly 43% of hospitalized women aged 50-75 who are current or former smokers are at intermediate to high risk for developing lung cancer, highlighting a significant population that could benefit from screening.

Despite the high risk, only 38% of these women had undergone a low-dose CT scan for lung cancer screening in the past year, indicating a gap in adherence to recommended screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of hospitalized women at high-risk for developing lung cancer. Gnanaraj, J., Ijaz, SH., Khaliq, W.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9311401/

Low‐dose computed tomography lung cancer screening The US National Lung Screening Trial reported a 20% overall reduction in lung cancer mortality when comparing LDCT to chest X‐ray, and the Nederlands‐Leuvens ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925003521

Review Current evidence of low-dose CT screening benefit Early results showed higher lung cancer detection rates in people who have never smoked with a family history of lung cancer (1.7 %) than in ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1102873

Reduced Lung-Cancer Mortality with Low-Dose Computed ... A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2777242

Screening for Lung Cancer With Low-Dose Computed ... The NLST found a reduction in all-cause mortality with LDCT screening compared with chest radiography (1912 vs 2039 deaths; 1141 per 100 000 ...

5. lungevity.org lungevity.org/blogs/low-dose-computed-tomography-and-beyond-advances-in-early-detection-of-lung-cancer

Advances in the Early Detection of Lung Cancer This approach achieved 87% accuracy in distinguishing cancerous from benign (non-cancerous) nodules, significantly outperforming current methods ...

6. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening

Recommendation: Lung Cancer: Screening The USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have at least a 20 pack-year smoking history.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4662564/

Assessing the benefits and harms of low-dose computed ... This article evaluates the benefits and harms of LDCT screening, based largely on evidence from randomized trials.

8. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274&bc=AAAAAAAAAgAAAA

Screening for Lung Cancer with Low Dose Computed ... The USPSTF recommends annual screening for lung cancer with low-dose computed tomography in adults ages 55 to 80 years who have a 30 pack-year smoking history ...

9. cancer.gov cancer.gov/types/lung/hp/lung-screening-pdq

Lung Cancer Screening (PDQ®) - NCI Lung cancer screening with low-dose spiral CT scans has been shown to decrease the risk of dying from lung cancer in heavy smokers.