Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer

Recruiting

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Chest X-ray Tomosynthesis

• Registration Number: NCT06577883
• Lead Sponsor: University of California, San Diego

Brief Summary

The goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. The main questions it aims to answer are:

* What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule?

* Can artificial intelligence help us detect lung cancer on chest tomosynthesis images?

Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer.

Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.

Detailed Description

Lung cancer remains the most common cause of cancer death in the United States for which low-dose CT has proven benefit for early detection and survival from lung cancer. However, adoption remains low. Furthermore, \>95% of nodules detected on low-dose CT, especially those smaller than 6 mm, do not represent cancer. We have partnered to develop a novel chest x-ray tomosynthesis (CXRT) device with the hypothesis that this device might be an alternative to CT for detection of lung cancer. We seek to recruit a cohort of patients to undergo CXRT, composed of patients concurrently undergoing lung cancer screening CT and diagnostic CT for new lung cancer. We will determine the effectiveness of CXRT for detecting lung cancer in this population, evaluating its sensitivity and specificity for detecting cancer and lung nodules at multiple size thresholds in a multireader study. We will additionally develop artificial intelligence algorithms and evaluate their efficacy to further enhance cancer detection.

Study Timeline

• Study Start: 2023-11-02
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• undergoing lung cancer screening
• undergoing evaluation of suspicious pulmonary nodule
• newly diagnosed lung cancer

Exclusion Criteria

• prior history of lung cancer treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chest X-ray Tomosynthesis Participants	Chest X-ray Tomosynthesis	Participants who had a recent, routine clinical chest computed tomography scan for lung cancer screening or evaluation of nodule suspicious for lung cancer will undergo an additional chest X-ray tomosynthesis scan.

Primary Outcome Measures

Name	Time	Method
Chest X-ray tomosynthesis detection of lung cancer	through 12/31/2026	Diagnostic accuracy of chest tomosynthesis in identifying biopsy-proven lung cancer

Secondary Outcome Measures

Name	Time	Method
Chest X-ray tomosynthesis detection of suspicious nodules	through 12/31/2026	Diagnostic accuracy of chest tomosynthesis in identifying pulmonary nodules seen on chest CT at multiple minimum size thresholds: 6-mm, 8-mm, 10-mm

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 San Diego, California, United States