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NCT04076696

Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

Completed NA Results posted Last updated 8 August 2022
What this trial tests

NA trial testing Scatter corrected s-DCT in Pulmonary Nodule, Solitary in 38 participants. Completed in 26 August 2021.

Timeline
26 August 2020
Primary endpoint
26 August 2021
26 August 2021

Quick facts

Lead sponsorUNC Lineberger Comprehensive Cancer Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment38
Start date26 August 2020
Primary completion26 August 2021
Estimated completion26 August 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Pulmonary Nodule, Solitary or Pulmonary Nodule, Multiple. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale) Primary · Baseline

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 b

GroupValue95% CI
Scatter Corrected s-DCT-0.43± 0.62
Sensitivity of s-DCT Images (Percentage of Positive Scans) Secondary · Baseline

Sensitivity will be defined as the ability of s-DCT images to detect lesions positively identified on gold standard CT images.

GroupValue95% CI
Scatter Corrected s-DCT0.4070.224 – 0.612

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Pulmonary Nodule, Solitary

Currently open trials in the same condition.

Other UNC Lineberger Comprehensive Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04076696.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing