Low-Dose CT Screening for Lung Cancer

(ILST Trial)

Not currently recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Queensland

Must not be taking: Antibiotics, Chemotherapy

Disqualifiers: Lung cancer, Severe heart disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best use of low-dose CT scans (a type of imaging test) for early detection of lung cancer, making treatment easier. It targets individuals aged 55 to 80 who smoke or have smoked and are at higher risk for lung cancer. Participants should recognize if they have a significant smoking history or currently smoke. The goal is to identify who benefits most from regular CT screenings to reduce lung cancer deaths. As an unphased trial, this study allows participants to contribute to important research that could lead to earlier detection and better outcomes for those at risk of lung cancer.

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. It's best to discuss this with the trial organizers or your doctor.

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

Past research has found that low-dose CT (computed tomography) scans reduce deaths from lung cancer, particularly in long-term smokers. This demonstrates the screening's effectiveness. However, some risks exist. Low-dose CT can produce false-positive results, indicating cancer when there is none, which may cause stress and lead to unnecessary tests. Although there is a small risk from radiation exposure, it is less than with regular CT scans. The U.S. Preventive Services Task Force recommends these scans for certain adults at higher risk of lung cancer, suggesting they are generally safe for these groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about low-dose CT screening for lung cancer because it offers a way to detect lung cancer early with significantly less radiation exposure compared to traditional CT scans. Unlike standard chest X-rays, which can miss early-stage lung cancers, low-dose CT scans provide more detailed images, improving the chances of spotting cancer when it's most treatable. This approach could lead to earlier interventions and potentially better outcomes for patients, making it a promising advancement in lung cancer screening.

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

Research has shown that low-dose CT scans can significantly reduce deaths from lung cancer. A major study found that individuals who underwent these scans had a 20% lower risk of dying from lung cancer compared to those who only received a simple chest X-ray. CT scans are beneficial because they can detect lung cancer early, when treatment is more manageable. Reviews confirm that this method helps identify lung cancer at stages where treatment is more effective. Overall, low-dose CT screening serves as a powerful tool for saving lives by detecting lung cancer sooner. ^{3 6 7 8 9}

Who Is on the Research Team?

Kwun M Fong

Principal Investigator

UQTRC at TPCH

Steven Lam

Principal Investigator

British Columbia Cancer Agency

Are You a Good Fit for This Trial?

This trial is for men and women aged 55-80 who are current or former smokers with a significant history of smoking (at least 30 pack-years) and an elevated risk of lung cancer. They must be able to undergo CT scans, have not had chest CTs in the past two years, no recent chemotherapy, and cannot have been previously diagnosed with lung cancer.

Inclusion Criteria

I am between 55 and 80 years old.

Capable of providing informed consent for screening procedures (low dose spiral CT)

I am currently smoking or have quit smoking for at least a year.

Exclusion Criteria

Unwilling to sign a consent

Chest CT within 2 years

I have symptoms like coughing up blood, chest pain, or losing weight unexpectedly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CT Screening

Participants undergo computed tomography (CT) screening of the chest to detect early lung cancer

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after CT screening

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Low dose CT

Trial Overview

The ILST is testing whether low-dose CT scans can effectively screen for early lung cancer in individuals at high risk due to their age and smoking history. The goal is to see if this screening method can reduce deaths from lung cancer by catching it earlier.

How Is the Trial Designed?

Group I: Single Experimental Treatment 1 Intervention

Single arm only, CT screening of lung

Who Is Running the Clinical Trial?

The University of Queensland

Lead Sponsor

Trials

149

Recruited

71,700+

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]

In a pilot study involving 7768 individuals, integrating smoking cessation (SC) services with low-dose computed tomography screening led to a high acceptance rate of SC referrals, with 69.8% of smokers opting for in-hospital programs.

The one-year quit rate for participants was 15.5%, and significant improvements were noted in smoking behaviors, such as reduced cigarette consumption and increased quit attempts, indicating the effectiveness of the integrated approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Smoking Cessation Into Low-Dose Computed Tomography Lung Cancer Screening: Results of the Ontario, Canada Pilot. Evans, WK., Tammemägi, MC., Walker, MJ., et al.[2023]

Lung cancer screening using low-dose CT (LDCT) has proven effective in clinical trials, including the National Lung Screening Trial, highlighting its importance in early detection.

The Lung CT Screening Reporting and Data System (Lung-RADS) is recommended for all LDCT exams to improve communication of results and reduce false-positive rates, ensuring better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Lung Cancer: Lexicon for Communicating With Health Care Providers. Carter, BW., Lichtenberger, JP., Wu, CC., et al.[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]

In a study of 11,520 individuals aged 55 to 80 who underwent lung cancer screening with low-dose CT (LDCT), the rates of follow-up imaging and procedures were found to be low, with 17.7% requiring imaging and only 3.1% undergoing procedures within 12 months.

The adjusted rates of specific follow-up procedures were also low, with bronchoscopy at 2.0% and percutaneous biopsy at 1.3%, indicating that while LDCT screening is beneficial, it does not lead to excessive follow-up interventions in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Imaging and Diagnostic Procedures After Low-Dose CT Screening for Lung Cancer. Nishi, SPE., Zhou, J., Okereke, I., et al.[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

LDCT screening has emerged as a powerful tool for early detection, enabling diagnosis at curable stages and reducing lung cancer mortality.

3.

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 noted that “screening with LDCT, CXR, or sputum cytology can detect lung cancer at an earlier stage than lung cancer would be detected in an ...

4.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK534580/

Clinical effectiveness outcome data - NCBI Bookshelf

At 1 month post CT scan, the mean SF-36 physical component measure was 44.50 for those with true positive results, 47.7 for those with false-positive results ...

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/PMC4662564/

Assessing the benefits and harms of low-dose computed ...

Harms include false-positive screens and resultant diagnostic procedures, overdiagnosed cancers, and radiation exposure. Benefits can be expressed as the number ...

7.

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.

8.

jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/2832778

Projected Lifetime Cancer Risks From Current Computed ...

Radiation-induced cancer risks from CT examinations vary by radiation dose, which depends on the clinical indication; body region imaged; patients' sex, age, ...

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.