N/A N=38 Diagnostic

Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

Pulmonary Nodule, Solitary · Pulmonary Nodule, Multiple

Bottom Line

View on ClinicalTrials.gov: NCT04076696 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: Primary: Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale) — -0.43 Units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Scatter corrected s-DCT (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UNC Lineberger Comprehensive Cancer Center
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale)	-0.43	—
SECONDARY Sensitivity of s-DCT Images (Percentage of Positive Scans)	0.407	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04076696). 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.