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

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

Firefighters are at increased risk for cancer due to exposure to carcinogenic substances. Current lung cancer screening guidelines are predominantly based on smoking history and do not take into account high risk occupational exposures such as firefighting. This study aims to provide chest computed tomography (CT) scans to firefighters to determine the prevalence of lung cancer, other cancers detectable on CT chest, and lung diseases associated with increased cancer risk.

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 data supports the effectiveness of the treatment Low-dose CT for Lung Cancer?

Research shows that using low-dose CT scans for lung cancer screening can reduce lung cancer deaths by 20% in high-risk individuals, like heavy smokers, by detecting cancer early when it's more treatable. ^{1 2 3 4 5}

Is low-dose CT for lung cancer screening safe for humans?

Low-dose CT for lung cancer screening is considered safe, with very low risks from radiation exposure, and it has become a standard practice in the U.S. due to its benefits outweighing the potential harms. ^{6 7 8 9 10}

How does low-dose CT for lung cancer differ from other treatments?

Low-dose CT (computed tomography) for lung cancer is unique because it uses a significantly reduced amount of radiation compared to standard CT scans, making it safer for regular screening, especially in high-risk populations. This approach is primarily used for early detection rather than treatment, helping to identify lung cancer at an earlier, more treatable stage. ^{7 11 12 13 14}

Research Team

Jae Ho Sohn, MD, MS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Screening for asymptomatic early bronchogenic carcinoma with low dose CT of the chest. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Screening for lung cancer using low dose CT scanning: results of 2 year follow up. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Prevalence of hospitalized women at high-risk for developing lung cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Author response to "lack of benefit from low dose computed tomography in screening for lung cancer". [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Bronchial carcinoma screening with low dosage CT. Current status]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Executive Summary: Screening for Lung Cancer: Chest Guideline and Expert Panel Report. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Screening for Lung Cancer: CHEST Guideline and Expert Panel Report. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Radiation risk of lung cancer screening. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

The Danish randomized lung cancer CT screening trial--overall design and results of the prevalence round. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Screening for Lung Cancer: CHEST Guideline and Expert Panel Report. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

[Low-dose spiral CT of the lung in the follow-up of non-malignant lung disease]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening: Computed Tomography Radiation and Protocols. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Organ Dose and Attributable Cancer Risk in Lung Cancer Screening with Low-Dose Computed Tomography. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Feasibility of a screening programme for lung cancer in former asbestos workers. [2016]