Clinical trial NCT02531646: Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
Official title: Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solitary Pulmonary Nodules
Keywords: pulmonary nodule
Lead sponsor: Carestream Health, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital Tomosynthesis (DE-DT) application against the commercially available predicate devices.

Detailed description: The acquisition system will consist of using site equipment including the CARESTREAM DRX-Evolution x-ray system, and the predicate CARESTREAM DRX Plus detector and the investigational DE-DT application.

DE Study Design Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).

DT Study Design Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.

11 phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.

Eligibility criteria: Inclusion Criteria:

Age 18 years and older. Subject has provided informed consent. Study participant is scheduled to have a chest CT exam. Study participant is able to stand and be still during the exams.

Exclusion Criteria:

Human subject specific:

Not able or willing to provide Informed Consent, or consent is withdrawn. Study participant is a female of child bearing age.

Primary outcomes:
measure: Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest
timeFrame: 3 months
measure: Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite
timeFrame: 3 months
measure: Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy
timeFrame: 3 months
measure: Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy
timeFrame: 3 months
measure: Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest
timeFrame: 3 months
measure: Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest
timeFrame: 3 months
measure: Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume
timeFrame: 3 month
measure: Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images
timeFrame: 3 months
measure: Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Toronto General Hospital
name: Narinder Paul, MD
role: PRINCIPAL_INVESTIGATOR
References: