LDCT Lung Screening for Early Detection of Lung Cancer

Overseen By Darcy Doege, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Daniel Carrizosa

Disqualifiers: Lung cancer, CT contraindication, pregnancy

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

1160 Participants Needed

Trial Summary

What is the purpose of this trial?

Low-dose CT Screening has been shown in two large trials in the United States (NLST) and Europe (NELSON) to increase overall survival in subjects 55 years of age and older with a strong smoking history. Unfortunately, in both North Carolina (NC) and South Carolina (SC), subjects are found to have the above referenced smoking history prior to reaching the minimum age in these studies. This study is aimed at decreasing the minimum age of screening in a high-risk population.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Mobile Low-dose Computed Tomography (LDCT) Screening for early detection of lung cancer?

Research shows that low-dose computed tomography (LDCT) screening can detect early-stage lung cancer and reduce mortality, making it a promising tool for reducing deaths from lung cancer. ^{1 2 3 4 5}

Is low-dose computed tomography (LDCT) screening safe for humans?

LDCT screening for lung cancer is generally considered safe, but there are concerns about increased radiation exposure, overdiagnosis of slow-growing tumors, and false-positive results that could lead to unnecessary procedures and anxiety. ^{6 7 8 9 10}

How is Mobile Low-dose Computed Tomography (LDCT) Screening different from other treatments for lung cancer?

Mobile Low-dose Computed Tomography (LDCT) Screening is unique because it is a non-invasive imaging technique used to detect lung cancer early in high-risk individuals, such as smokers, by using lower doses of radiation compared to standard CT scans. Unlike treatments that address existing cancer, LDCT is used for early detection, which can significantly reduce lung cancer mortality by identifying cancer at a stage when it is more treatable. ^{5 9 11 12 13}

Research Team

Daniel Carrizosa, MD

Principal Investigator

LCI

Eligibility Criteria

This trial is for people aged 40-54 who have a significant smoking history (at least 30 pack years), are currently smoking or quit within the last 15 years, and can understand English/Spanish. They must consent to share health information and follow study procedures. Those with past lung cancer diagnosis, CT scan contraindications, or pregnancy cannot join.

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

I am between 40 and 54 years old.

I have smoked for 30 or more years and quit less than 15 years ago, if at all.

Exclusion Criteria

Any known contraindication to having a low-dose CT Scan.

Known pregnancy.

I was diagnosed with lung cancer within the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Initial Screening (T0)

Participants undergo their first mobile low-dose CT screening to evaluate lung cancer diagnosis rate

1 day

1 visit (in-person)

Subsequent Screenings (T1 and T2)

Participants undergo subsequent mobile low-dose CT screenings to evaluate lung cancer diagnosis rate and positive screening rate

up to 24 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after screenings

up to 24 months

Treatment Details

Interventions

• Mobile Low-dose Computed Tomography (LDCT) Screening

Trial Overview The study tests if lowering the age for Low-dose Computed Tomography (LDCT) screening can help detect lung cancer earlier in smokers or recent quitters aged 40-54. This follows evidence that LDCT improves survival rates in older individuals.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Mobile Low-dose Computed Tomography (LDCT) Screening

Mobile Low-dose Computed Tomography (LDCT) Screening is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Low-dose CT Screening for:

• Lung cancer screening for high-risk populations aged 55 and older
• Experimental use for ages 40-54 in specific studies

Approved in European Union as LDCT Screening for:

• Lung cancer screening for high-risk populations aged 55 and older

Approved in Canada as Low-dose CT Screening for:

• Lung cancer screening for high-risk populations aged 55 and older

Who Is Running the Clinical Trial?

Daniel Carrizosa

Lead Sponsor

Trials

1

Recruited

1,200+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Leon Levine Foundation

Collaborator

Trials

1

Recruited

1,200+

Findings from Research

Targeting lung cancer screening using low-dose computed tomography (LDCT) to individuals at higher risk for lung cancer mortality can prevent more deaths, with benefits ranging from 1.2 to 9.5 deaths prevented per 10,000 person-years based on risk deciles.

However, the overall gains in life-years and quality-adjusted life-years (QALYs) are modest, with similar cost-effectiveness ratios across risk groups, suggesting that while risk-targeting improves early mortality outcomes, it does not significantly enhance overall efficiency in terms of life extension or cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-Targeted Lung Cancer Screening: A Cost-Effectiveness Analysis. Kumar, V., Cohen, JT., van Klaveren, D., et al.[2022]

In a study of 272 patients screened for lung cancer using low dose computed tomography (LDCT), the lung cancer detection rate was 2.2%, which aligns with findings from the National Lung Screening Trial, indicating the efficacy of LDCT in identifying lung cancer.

The implementation of LDCT screening highlighted the importance of thorough pre-screening evaluations and careful scanning protocols to ensure patient safety, with a mean radiation dose of 3.12 mGy achieved through techniques like tube current modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose Lung Cancer Screening at an Academic Medical Center: Initial Experience and Dose Reduction Strategies. Ahmed, A., Verma, N., Barreto, I., et al.[2019]

The LungSEARCH trial, involving 1568 participants, tested a sequential lung cancer screening strategy using sputum samples to identify high-risk individuals for further testing, but it did not significantly increase the diagnosis of early-stage lung cancer compared to standard methods.

The overall sensitivity of sputum testing was low at 40.5%, and many lung cancers (55%) had normal sputum results, indicating that this approach may not be effective for improving lung cancer screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential screening for lung cancer in a high-risk group: randomised controlled trial: LungSEARCH: a randomised controlled trial of Surveillance using sputum and imaging for the EARly detection of lung Cancer in a High-risk group. Spiro, SG., Shah, PL., Rintoul, RC., et al.[2020]

Oncology nurse navigation significantly improved provider education about low-dose computed tomography (LDCT) lung cancer screening, leading to better discussions about tobacco cessation and increased adherence to screening protocols.

During a five-month intervention involving 133 eligible patients, the time taken for providers and patients to be notified about LDCT results was significantly reduced, indicating enhanced efficiency in the screening process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Dose Computed Tomography: Effects of Oncology Nurse Navigation on Lung Cancer Screening. Watson, J., Broome, ME., Schneider, SM.[2021]

In a study involving 8649 asymptomatic volunteers aged 50 to 75 with significant smoking histories, lung cancer screening using low-dose computed tomography (LDCT) detected lung cancer in 107 patients (1.24%), indicating the program's effectiveness in identifying cases early.

The majority of lung cancers were diagnosed at an early stage (Stage I non-small cell lung cancer in 79% of surgical patients), and the screening program had no perioperative deaths, highlighting its safety and potential for curative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of an open-access lung cancer screening program with low-dose computed tomography: the Gdańsk experience. Rzyman, W., Dziedzic, R., Jelitto-Górska, M., et al.[2019]

Low-dose computed tomography (LDCT) screening can detect lung cancers at earlier stages, leading to a 20% reduction in cancer-related deaths.

While LDCT screening shows significant potential benefits for certain patients, there are still many unanswered questions regarding its practical application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography screening for lung cancer: where are we now? Christensen, JD., Tong, BC.[2021]

In a study of 121 patients who underwent low-dose computed tomography (LDCT) screening for lung cancer, the overall adherence rate to follow-up scans was only 59.1%, indicating a need for improved compliance with screening guidelines.

Patients with more concerning findings (Lung-RADS score 2) were 2.43 times more likely to adhere to follow-up scans compared to those with less concerning findings (Lung-RADS score 1), while African American patients showed lower odds of adherence, highlighting potential socioeconomic disparities in lung cancer screening compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. Mortman, KD., Devlin, J., Giang, B., et al.[2023]

Lung cancer screening using low-dose computed tomography (LDCT) can reduce lung cancer mortality by 20% in high-risk populations, based on a class I clinical trial.

However, there are significant concerns about LDCT screening, including risks from radiation exposure, the potential for overdiagnosis of non-threatening tumors, and high rates of false positives, which can lead to unnecessary anxiety and procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective use of low-dose computed tomography lung cancer screening. Jeffers, CD., Pandey, T., Jambhekar, K., et al.[2016]

Low-dose computed tomography (LDCT) effectively detects asymptomatic lung cancer in high-risk individuals, with a lung cancer detection rate of 1.21% in the high-risk group and 2.01% in heavy smokers, compared to 0.51% overall in the study of 1551 adults.

The study highlights that the detection rate of lung cancer increases with the number of risk factors, demonstrating LDCT's potential as a sensitive screening tool for lung cancer in populations with varying levels of risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application value of low-dose computed tomography for the screening of lung cancer in high-risk group]. Lei, Y., Chen, BJ., Zeng, L., et al.[2016]

Annual low-radiation-dose computed tomography (LDCT) screening can significantly reduce lung cancer mortality in high-risk individuals, but its implementation requires careful planning to maximize benefits and minimize harms.

The American Thoracic Society and American College of Chest Physicians provide a framework for developing LDCT screening programs, outlining essential strategies for planning, implementation, and maintenance to ensure these programs are safe, effective, and sustainable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. Wiener, RS., Gould, MK., Arenberg, DA., et al.[2022]

The Lung Cancer Causal Model (LCCM) developed from a study of 218 subjects effectively distinguishes between malignant and benign lung nodules using key factors like nodule and vessel counts and smoking history, improving predictive accuracy over existing models.

LCCM can identify 30% of benign nodules without misclassifying cancerous ones, potentially reducing unnecessary follow-ups and procedures in lung cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of lung cancer prediction from low-dose CT scan and smoking factors using causal models. Raghu, VK., Zhao, W., Pu, J., et al.[2022]

In a study of 13,831 smokers aged 55-74, screening for lung cancer using low-dose chest CT (LDCT) showed a significant reduction in lung cancer mortality after the first year for those with obstructive lung disease (OLD), with a hazard ratio of 0.63 (indicating a 37% reduction in risk).

The number needed to screen to prevent one lung cancer death in patients with OLD was 108, which is more favorable compared to 218 for those without OLD, suggesting that LDCT screening is particularly beneficial for high-risk individuals with OLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Impact of Lung Cancer Screening on Lung Cancer Mortality of Smokers With Obstructive Lung Disease: Analysis of the NLST-ACRIN Cohort. de-Torres, JP., Wisnivesky, JP., Bastarrika, G., et al.[2021]

Low-dose computed tomography (LDCT) screening significantly detects more stage I lung cancers and total lung cancers compared to chest X-ray or usual care in high-risk individuals over 49 years old with smoking exposure.

While LDCT screening reduces lung cancer-specific mortality, it does not lower overall mortality rates and is associated with a higher rate of false positives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis: is low-dose computed tomography a superior method for risky lung cancers screening population? Fu, C., Liu, Z., Zhu, F., et al.[2017]

References

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

Risk-Targeted Lung Cancer Screening: A Cost-Effectiveness Analysis. [2022]

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

Low-dose Lung Cancer Screening at an Academic Medical Center: Initial Experience and Dose Reduction Strategies. [2019]

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

Sequential screening for lung cancer in a high-risk group: randomised controlled trial: LungSEARCH: a randomised controlled trial of Surveillance using sputum and imaging for the EARly detection of lung Cancer in a High-risk group. [2020]

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

Low-Dose Computed Tomography: Effects of Oncology Nurse Navigation on Lung Cancer Screening. [2021]

5. Poland pubmed.ncbi.nlm.nih.gov

Results of an open-access lung cancer screening program with low-dose computed tomography: the Gdańsk experience. [2019]

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

Computed tomography screening for lung cancer: where are we now? [2021]

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

Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. [2023]

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

Effective use of low-dose computed tomography lung cancer screening. [2016]

9. China pubmed.ncbi.nlm.nih.gov

[Application value of low-dose computed tomography for the screening of lung cancer in high-risk group]. [2016]

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

An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Feasibility of lung cancer prediction from low-dose CT scan and smoking factors using causal models. [2022]

12. Spain pubmed.ncbi.nlm.nih.gov

Exploring the Impact of Lung Cancer Screening on Lung Cancer Mortality of Smokers With Obstructive Lung Disease: Analysis of the NLST-ACRIN Cohort. [2021]

13. England pubmed.ncbi.nlm.nih.gov

A meta-analysis: is low-dose computed tomography a superior method for risky lung cancers screening population? [2017]