NCT04076696

Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulmonary Nodule, Solitary
• Pulmonary Nodule, Multiple

Interventions

Type	Name	Description
DEVICE	Scatter corrected s-DCT	All patients will have a breath held s-DCT scan in an anterior-posterior direction

Timeline

• Start date: 2020-08-26
• Primary completion: 2021-08-26
• Completion: 2021-08-26
• First posted: 2019-09-03
• Last updated: 2022-08-08
• Results posted: 2022-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study