Low-Dose CT Screening for Lung Cancer

(ILST Trial)

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

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

People who may be at increased risk of lung cancer due to age and smoking history will be invited to participate in this international study to determine the best way of using computed tomography (CT) of the chest to screen for early lung cancer. Overseas data show that CT screening (screening tests can find diseases early, when they're easier to treat) can reduce deaths from lung cancer and this study will help determine who is most likely benefit from screening.

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 data supports the effectiveness of the treatment Low dose CT for lung cancer?

Research shows that low-dose CT screening can reduce lung cancer deaths by 20% in high-risk individuals, as demonstrated in multiple clinical trials, including the National Lung Screening Trial. ^{1 2 3 4 5}

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

Low-dose CT screening for lung cancer is generally considered safe, but it can have potential harms, mainly related to follow-up procedures after abnormal results. The benefits and harms have been studied, and guidelines recommend informing patients about these during decision-making. ^{6 7 8 9 10}

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

Low-dose CT screening for lung cancer is unique because it is a preventive tool that uses a lower amount of radiation compared to standard CT scans, aiming to detect lung cancer early in high-risk individuals, which can reduce lung cancer mortality by 20%. Unlike other treatments that focus on managing or curing cancer, this screening method is about early detection and prevention. ^{3 11 12 13 14}

Research Team

Kwun M Fong

Principal Investigator

UQTRC at TPCH

Steven Lam

Principal Investigator

British Columbia Cancer Agency

Eligibility Criteria

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

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

I have cancer outside the lung that was not treated to cure.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Screening for Lung Cancer: Lexicon for Communicating With Health Care Providers. [2018]

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

Integrating Smoking Cessation Into Low-Dose Computed Tomography Lung Cancer Screening: Results of the Ontario, Canada Pilot. [2023]

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

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

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

Definition of a positive test result in computed tomography screening for lung cancer: a cohort study. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Is lung cancer screening using CT a good idea?]. [2011]

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

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

7. United States 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. [2021]

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

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

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

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

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

Use of Imaging and Diagnostic Procedures After Low-Dose CT Screening for Lung Cancer. [2023]

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

Computed tomography screening for lung cancer. [2022]

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

Tobacco treatment in the setting of lung cancer screening. [2023]

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

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