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

NCT02075320 | Completed Results

• 1 other identifier: LCCC1337
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Signs and Symptoms

Keywords

CT; Chest; Lung

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Sensitivity for our study is defined as the ability of s-DCT to detect a lung lesion known to exist based on non-contrast CT (the gold standard) for any sized lung nodule.

  1 year following imaging

• Specificity

  Specificity for our study is defined as the ability of s-DCT to correctly identify the absence of a lung nodule as confirmed by CT (gold standard).

  1 year following imaging

Secondary Outcomes (2)

• Specificity of s-DCT (Percentage) for Malignant Lesions.

  1 year following imaging

• Reader Preference

  1 year following imaging

Study Arms (1)

Stationary Digital Chest Tomosynthesis

EXPERIMENTAL

All patients will be included in the experimental group.

Device: Stationary Digital Chest Tomosynthesis

Interventions

Stationary Digital Chest Tomosynthesis DEVICE

The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR. Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction.

Stationary Digital Chest Tomosynthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Hospital

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Our analysis focused on all lung nodules detected by conventional CT imaging, and thus the sensitivity and specificity may not reflect clinically relevant (i.e. greater than 5 mm) lung nodules.

Results Point of Contact

• Title: Dr. Yueh Lee
• Organization: UNC School of Medicine Department of Radiology

yueh_lee@med.unc.edu

(919) 537-3730

Study Officials

• Yueh Lee, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: August 9, 2016
• Study Completion: August 9, 2016
• Last Updated: May 18, 2022
• Results First Posted: May 18, 2018

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)