Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

Pulmonary Nodule, Solitary Clinical Trial

Official title:

Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076696
• Other study ID #: LCCC1822
• Secondary ID: 18-11441R21CA216
• Status: Completed
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: August 26, 2021

Study information

• Verified date: August 2022
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study that will evaluate the utility of a scatter reduction technique in reducing dose and increasing the sensitivity of stationary digital chest tomosynthesis (s-DCT) in the detection of lung lesions.

Description:

Digital tomosynthesis is an imaging modality that produces 3D sectional information using x-ray projections acquired over a limited scanning angle. Scatter is known to be the primary source of image degradation in x-ray based imaging.

The investigators have developed an approach that measures scatter through a low dose (3% of the conventional scan) scatter measurement technique. Preliminary studies have shown that scatter reduction in DCT can significantly improve quality. The approach will characterize the reader confidence in lung nodule detection in a scatter corrected chest tomosynthesis imaging approach as compared to the conventional chest tomosynthesis.

Fifty (50) patients who have undergone a clinical non-contrast CT with lung nodules will be asked to have an s-DCT (scan) within 4 weeks (+/- 2 week) of their clinical CT with no intervening procedures or therapies (i.e. biopsy of lung nodules). Investigators will then perform a reader study to evaluate the radiologist reader confidence in images generated from the scatter reduction technique versus more conventional chest tomosynthesis imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 26, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with known lung lesion(s)

• Patients having undergone a chest CT

• Patients 18 years of age and older

• Patients able to provide informed consent

Exclusion Criteria:

• Patients who may not fit on a 35 x 35 detector (BMI > 35)

• Planned procedures or therapies during study (in between SOC scans and study scan on s-DCT) (biopsy or removal of lung lesion)

• Any woman who is pregnant, has reason to believe she is pregnant, or is lactating

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Multiple
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Device:
• Scatter corrected s-DCT
All patients will have a breath held s-DCT scan in an anterior-posterior direction

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale)	Readers will rate their confidence in images from the experimental modality (sDCT with scatter correction) as compared to the conventional scan (chest CT with x-ray) on a 7 point Likert scale (-3 to 3) based on ability to identify lesion(s) present comparing each modality. A value of -3 is significantly less confident in the s-DCT representation 0 is the same confidence in modalities, and 3 is significantly more confident in the s-DCT representation compared to the conventional. Each individual will have a single value per reader. Two readers compared each scan. The overall reader preference between modalities was calculated by determining the mean value.	Baseline
Secondary	Sensitivity of s-DCT Images (Percentage of Positive Scans)	Sensitivity will be defined as the ability of s-DCT images to detect lesions positively identified on gold standard CT images.	Baseline