Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis

Carestream

Status: Completed

Conditions: Solitary Pulmonary Nodules

Treatments: Radiation: Radiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02531646

9J8068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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Not able or willing to provide Informed Consent, or consent is withdrawn.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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Predicate & Invest. DE - Human Subjects

Experimental group

Description:

Radiation -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).

Treatment:

Radiation: Radiation

Predicate & Invest. DT - Human Subjects

Experimental group

Description:

Radiation - 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.

Treatment:

Radiation: Radiation

Predicate & Invest. DT - Phantom Images

Experimental group

Description:

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

Treatment:

Radiation: Radiation