LDCT Screening for Lung Cancer in High-risk Black Women

Recruiting at 1 trial location

Overseen By Chi Fu Jeffrey Yang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Lung cancer, Lung symptoms, Pneumonia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of low-dose computed tomography (LDCT) scans in detecting lung cancer early in Black women with a history of smoking. The focus is on assessing the acceptability and effectiveness of these scans for this group. Women who identify as Black, have a history of smoking, and are at least 50 years old are encouraged to consider joining. Participants will complete questionnaires and undergo an LDCT scan to assist researchers in assessing the screening process. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance early detection methods for lung cancer in their community.

Will I have to stop taking my current medications?

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

What prior data suggests that low-dose computed tomography is safe for lung cancer screening?

Research has shown that low-dose computed tomography (LDCT) is a safe method for screening lung cancer. In the National Lung Screening Trial, LDCT significantly reduced lung cancer deaths in high-risk individuals. The study also demonstrated that LDCT lowered overall mortality compared to regular chest X-rays. However, LDCT can sometimes produce false positives, mistakenly indicating cancer when none is present, a common issue in many screening tests. Overall, LDCT is well-tolerated and considered safe for early lung cancer detection, potentially leading to better health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Low-dose Computed Tomography (LDCT) screening is unique because it offers a way to detect lung cancer early in high-risk individuals, potentially before symptoms appear. Unlike traditional chest X-rays, LDCT uses a lower dose of radiation while providing more detailed images of the lungs, increasing the chances of catching cancer at an earlier, more treatable stage. Researchers are excited about LDCT because it's a non-invasive method that can lead to early intervention, which is crucial for improving survival rates and outcomes in lung cancer patients.

What evidence suggests that low-dose computed tomography is effective for lung cancer screening in high-risk Black women?

Research has shown that low-dose computed tomography (LDCT) effectively detects lung cancer early. Studies have found that LDCT can reduce the risk of dying from lung cancer by about 20%. People screened with LDCT have a better chance of surviving lung cancer than those who are not screened. LDCT can also detect lung cancer at an earlier stage, when treatment is more likely to succeed. This method is especially beneficial for individuals with a history of heavy smoking, as it lowers their risk of dying from lung cancer. Participants in this trial will undergo LDCT screening to evaluate its effectiveness in high-risk Black women. ^{2 3 4 6 7}

Who Is on the Research Team?

Chi Fu Jeffrey Yang, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for self-identified Black women aged 50 or older who have a history of smoking. There are no specific requirements on the amount they've smoked or how long ago they quit. Women with recent lung infections treated with antibiotics, a history of lung cancer, or current symptoms suggesting lung cancer (like shortness of breath, getting winded easily, chronic cough) cannot join.

Inclusion Criteria

You have a history of smoking, regardless of how much or for how long.

I am 50 years old or older.

I am a Black woman.

Exclusion Criteria

I have symptoms like shortness of breath, getting easily winded, or a chronic cough in the last 12 weeks.

I was treated with antibiotics for pneumonia or a lung infection in the last 12 weeks.

I have had lung cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Questionnaire Completion

Participants complete questionnaires pre- and post- low-dose computed tomography (LDCT) test

1 week

2 visits (virtual)

LDCT Screening

Participants undergo a low-dose computed tomography (LDCT) screening test at Massachusetts General Hospital

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after LDCT screening

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Low-dose Computed Tomography

Trial Overview

The study is examining low-dose computed tomography (LDCT), which is a type of chest scan that uses less radiation than standard CT scans. It aims to check if this screening method is practical, acceptable and effective specifically in high-risk Black women smokers for early detection of lung cancer.

How Is the Trial Designed?

Group I: Screening: Low-Dose Computed Tomography Screening Experimental Treatment 1 Intervention

Participants will undergo study procedures as outlined: * Complete questionnaires pre- and post- low-dose computed tomography (LDCT) test. * Visit Massachusetts General Hospital facility for a LDCT screening test.

Low-dose Computed Tomography is already approved in United States, European Union for the following indications:

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

• Lung cancer screening in high-risk individuals aged 50 to 80 years with a 20 pack-year smoking history and currently smoke or have quit within the past 15 years

Approved in European Union as Low-dose CT scan for:

• Lung cancer screening in high-risk individuals

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Effective lung cancer screening with low-dose CT (LDCT) can reduce mortality by approximately 20%, but requires a well-organized system including quality assessment criteria and a nodule management algorithm.

To maximize the benefits and minimize risks, a network of accessible pulmonologists and expert treatment centers, along with robust IT infrastructure and cancer registry linkages, is essential for successful implementation of screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening by Low-Dose Computed Tomography: Part 2 - Key Elements for Programmatic Implementation of Lung Cancer Screening. Delorme, S., Kaaks, R.[2022]

Low-dose computed tomography (LDCT) screening significantly reduced lung cancer mortality in black individuals, with a hazard ratio of 0.61, indicating a greater benefit compared to other racial groups.

Despite higher overall mortality rates among black individuals due to factors like smoking and comorbidities, those who underwent LDCT screening experienced a reduction in all-cause mortality, highlighting the need for targeted healthcare access and screening efforts in this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial Differences in Outcomes within the National Lung Screening Trial. Implications for Widespread Implementation. Tanner, NT., Gebregziabher, M., Hughes Halbert, C., et al.[2022]

From 2011 to 2018, the use of low-dose computed tomography (LDCT) for lung cancer screening in Veterans increased significantly, with initial screenings rising from 0 to 29.6 per 1000 eligible Veterans, indicating growing awareness and implementation of this early detection strategy.

Despite the increase, overall LDCT utilization remained low, highlighting the need for further interventions to encourage more Veterans to participate in lung cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Lung Cancer Screening Utilization Trends in the Veterans Health Administration. Lewis, JA., Samuels, LR., Denton, J., et al.[2022]

Low-dose computed tomography (LDCT) screening has been shown to significantly reduce lung cancer mortality in high-risk populations, as demonstrated by the National Lung Screening Trial (NLST) in 2011.

While LDCT screening offers substantial benefits in reducing lung cancer deaths, it also carries risks such as false positives, overdiagnosis, and radiation exposure, which need to be carefully monitored as screening becomes more widespread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the benefits and harms of low-dose computed tomography screening for lung cancer. Pinsky, PF.[2020]

Lung cancer screening using low-dose helical computed tomography (LDCT) significantly improves the chances of early diagnosis and increases survival rates for high-risk individuals.

Identifying risk factors and qualifying patients for LDCT screening is crucial, and healthcare professionals, especially nurses, play a vital role in supporting and educating patients about the screening process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for Lung Cancer Screening: What Nurses Need to Know. Sorrie, K., Cates, L., Hill, A.[2017]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9311401/

Low‐dose computed tomography lung cancer screening

This trial reported an overall 20% (95% confidence interval [CI], 6.8–26.7; p = 0.004) reduction in lung cancer mortality after 6.5‐years follow‐up when using ...

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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.

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.

5.

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]).

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4662564/

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

In 2011, the National Lung Screening Trial (NLST) reported that LDCT screening significantly reduced mortality from lung cancer in a high risk population.

7.

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 ...