~157 spots leftby Jan 2026

LDCT Lung Screening for Early Detection of Lung Cancer

DC
Overseen byDaniel Carrizosa, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Daniel Carrizosa
Disqualifiers: Lung cancer, CT contraindication, pregnancy
No Placebo Group
Approved in 3 Jurisdictions

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.12345

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.678910

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.59111213

Research Team

DC

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.
See 2 more

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.

Trial 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 (Procedure)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Mobile Low-dose Computed Tomography (LDCT) Screening

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

🇨🇦
Approved in Canada as Low-dose CT Screening for:
  • Lung cancer screening for high-risk populations aged 55 and older

Find a Clinic Near You

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.
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.
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.
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]

References

Risk-Targeted Lung Cancer Screening: A Cost-Effectiveness Analysis. [2022]
Low-dose Lung Cancer Screening at an Academic Medical Center: Initial Experience and Dose Reduction Strategies. [2019]
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]
Low-Dose Computed Tomography: Effects of Oncology Nurse Navigation on Lung Cancer Screening. [2021]
Results of an open-access lung cancer screening program with low-dose computed tomography: the Gdańsk experience. [2019]
Computed tomography screening for lung cancer: where are we now? [2021]
Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. [2023]
Effective use of low-dose computed tomography lung cancer screening. [2016]
[Application value of low-dose computed tomography for the screening of lung cancer in high-risk group]. [2016]
10.United Statespubmed.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]
Feasibility of lung cancer prediction from low-dose CT scan and smoking factors using causal models. [2022]
Exploring the Impact of Lung Cancer Screening on Lung Cancer Mortality of Smokers With Obstructive Lung Disease: Analysis of the NLST-ACRIN Cohort. [2021]
A meta-analysis: is low-dose computed tomography a superior method for risky lung cancers screening population? [2017]