N/A N=50 Screening

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

Signs and Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT02075320 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Sensitivity — 53 percentage of positive scans

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Stationary Digital Chest Tomosynthesis (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UNC Lineberger Comprehensive Cancer Center
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity	53	—
PRIMARY Specificity	26	—
SECONDARY Specificity of s-DCT (Percentage) for Malignant Lesions.	—	—
SECONDARY Reader Preference	-2.2	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

≥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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02075320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.