Cancer Screening for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Must not be taking: Proscar, Propecia, Finasteride

Disqualifiers: Cancer treatment, Prior PLCO cancers, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if X-ray imaging (radiography) can detect lung cancer early, potentially reducing mortality. Participants will receive chest X-rays at the start and annually for two years. Smokers will receive an additional X-ray in the third year. Current or former smokers who have not received cancer treatment in recent years may qualify. As an unphased trial, this study provides a unique opportunity to contribute to important research that could lead to earlier lung cancer detection.

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

The trial protocol does not specify if you need to stop taking your current medications. However, men who are taking finasteride or Tamoxifen, and women who are taking Tamoxifen or Evista/Raloxifene, are allowed to participate.

What prior data suggests that X-Ray Imaging is safe for lung cancer screening?

Research has shown that chest X-rays are generally easy for people to handle. They are commonly used in healthcare and are known to be safe. However, chest X-rays use a small amount of radiation, much less than a CT scan.

While safe, X-rays have some limitations. Studies indicate that chest X-rays can detect lung cancer about 77% to 80% of the time, meaning they might miss some cases.

There is also a chance of false positives, where the test suggests cancer when there isn't any. Despite this, chest X-rays are considered a low-risk procedure for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of using X-ray imaging as a tool for early lung cancer screening. Unlike traditional methods, like CT scans, which are more detailed but expensive and involve higher radiation exposure, X-rays offer a simpler, more accessible, and lower-cost screening option. The trial aims to see if regular X-ray screenings can effectively identify lung cancer in high-risk individuals, like smokers, earlier than usual, potentially improving outcomes and saving lives.

What evidence suggests that X-Ray Imaging is effective for lung cancer screening?

Research has shown that chest X-rays alone do not reduce lung cancer deaths in the general population. In this trial, participants in the "Lung Screening" arm will undergo chest X-rays to monitor lung conditions. Studies have found that while chest X-rays can detect lung cancers, they do not necessarily lead to fewer deaths from the disease. X-rays can sometimes produce false positives, suggesting cancer is present when it is not. Additionally, X-rays might not detect tumors early enough to significantly impact outcomes. Therefore, while X-rays can help monitor lung conditions, they are not very effective at reducing lung cancer deaths on their own. ^{6 7 8 9 10}

Who Is on the Research Team?

Christine D Berg

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for older individuals who may be at risk of lung cancer. Participants will undergo screening methods to detect any signs of cancer early on, which could lead to better treatment outcomes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lung Screening

Participants undergo a chest x-ray at baseline and annually for 2 years, with additional x-ray at year 3 for smokers

3 years

Annual visits for chest x-ray

Follow-up

Participants are monitored for lung cancer incidence and mortality for at least 13 years

13 years

Annual follow-up via mailed questionnaire

What Are the Treatments Tested in This Trial?

Interventions

• X-Ray Imaging

Trial Overview The study is testing the effectiveness of a screening questionnaire and X-ray imaging in identifying lung cancer in its early stages, with the goal of reducing mortality from this disease.

How Is the Trial Designed?

Group I: Lung Screening Active Control 2 Interventions

Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3. Participants complete a BQF/M at baseline. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident lung cancers as all deaths that occur among both screened and control subjects during the trial.

Group II: Control Active Control 1 Intervention

Participants receive standard medical care. Participants complete a DHQ at baseline.

X-Ray Imaging is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in United States as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in Canada as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in Japan as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in China as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Approved in Switzerland as X-Ray Imaging for:

• Diagnostic imaging for various medical conditions, including pelvic sarcomas

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Lung cancer screening using low-dose chest CT scans can significantly reduce lung cancer mortality in a very high-risk group, highlighting its efficacy as a preventive measure.

Successful implementation of lung cancer screening programs requires addressing 11 identified obstacles, emphasizing the need for a multi-disciplinary approach and viewing screening as a comprehensive program rather than just a single test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstacles to and Solutions for a Successful Lung Cancer Screening Program. Mazzone, PJ.[2018]

A patient decision aid (PDA) significantly improved smokers' preparedness for making decisions about lung cancer screening compared to standard educational materials, with 67.4% of PDA users feeling well-prepared versus 48.2% of those using standard education.

Participants using the PDA reported feeling more informed and clearer about their values regarding the benefits and harms of screening, but there was no difference in actual screening intentions or behaviors between the PDA and standard education groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial. Volk, RJ., Lowenstein, LM., Leal, VB., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7781405/

Chest X-ray Screening Improves Outcome in Lung Cancer. ... Chest X-ray Screening Improves Outcome in Lung Cancer. A Reappraisal of Randomized Trials on Lung Cancer Screening.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0887217124000477

The Role of Chest Radiography in Lung Cancer Chest radiography is a useful tool to monitor for post-therapeutic complications and to stratify which patients may benefit from advanced imaging.

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

Lung Cancer Screening (PDQ®) - NCI Based on solid evidence, screening with chest x-ray and/or sputum cytology does not reduce mortality from lung cancer in the general population ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.2020201240

Performance of a Deep Learning Algorithm Compared with ... Clearly visible lung cancers were correctly detected on 28 of 28 chest radiographs (sensitivity, 100%). The specificity, NPV, and PPV of the ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7368999/

Lung cancer screening - PMC False positive results. In the NLST, 26% of all LDCT screening tests were positive and nearly 40% of all participants had at least one positive result.

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

Recommendation: Lung Cancer: Screening The NLST also found a reduction in all-cause mortality with LDCT screening compared with chest radiography (IRR, 0.93 [95% CI, 0.88-0.99]).

8. bjgp.org bjgp.org/content/69/689/e827

Sensitivity of chest X-ray for detecting lung cancer in ... The highest-quality studies suggest that the sensitivity of chest X-ray for symptomatic lung cancer is only 77% to 80%.

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

Screening for Lung Cancer with Low Dose Computed ... Use this page to view details for the decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N).

10. radiologyinfo.org radiologyinfo.org/en/info/screening-lung

Lung Cancer Screening LDCT produces images of sufficient quality to detect many abnormalities while using up to 90 percent less ionizing radiation than a conventional chest CT scan.