Evaluation of the Lung Nodule Sensitivity of Stationary Chest Tomosynthesis in Patients With Known Lung Nodules

Completed · Not applicable

Conditions studied: Signs and Symptoms

In brief

Purpose: The proposed research, if successfully implemented, will result in a low-dose, low-cost, and highly effective method for screening of lung cancer, leading to reduction of the lung cancer mortality rate. Using the stationary Digital Chest Tomosynthesis (s-DCT) system the imaging dose for a full tomosynthesis scan is expected to be only 10% of that from a low-dose computed tomography (CT). The targeted imaging time of 2s is 1/5 to 1/3 of that from a current commercial digital chest tomosynthesis (DCT) system at the same imaging dose. Beyond lung cancer screening, the low-dose and sensitive 3D lung imaging modality will likely to find applications in areas such as monitoring of pediatric cystic fibrosis patients where reduction of imaging dose is critical. Participants: One hundred (100) patients undergoing a clinical non-contrast CT for their lung nodules will be asked to have this procedure (scan) within 2 weeks (+/- 1 week) of their clinical CT and chest radiograph, with no intervening procedures or therapies. Procedures (methods): The purpose and endpoint of this study is to compare the sensitivity of the s-DCT system to the conventional chest radiographs with non-contrast chest CT as the reference standard. One hundred (100) patients undergoing a clinical non-contrast CT for their lung nodules will be asked to have this procedure (scan) within 2 weeks (+/- 1 week) of their clinical CT and chest radiograph, with no intervening procedures or therapies.

Key facts

Study ID

NCT02075320

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

50

Starts

2014-02-01

Expected to finish

2016-08-09

Last updated by the study team

2022-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age
• Known lung lesion(s) based on SOC non-contrast CT
• Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT
• Undergone a non-contrast chest CT in a time frame that will accommodate experimental imaging (s-DCT) within 2 weeks
• Institutional Review Board (IRB) written informed consent obtained and signed

You may not qualify if…

• Unable to provide consent
• Pregnant or lactating
• BMI > 33 (Patients who may not fit on a 35 x 35 detector)
• Planned procedures or therapies in between SOC scans and study scan on s-DCT, e.g., biopsy or excision of lung lesion

Where it is running

• UNC Hospital — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.