Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
Solitary Pulmonary Nodules
About this trial
This is an interventional diagnostic trial for Solitary Pulmonary Nodules focused on measuring pulmonary nodule
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Not able or willing to provide Informed Consent, or consent is withdrawn.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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Predicate & Invest. DE - Human Subjects
Predicate & Invest. DT - Human Subjects
Predicate & Invest. DT - Phantom Images
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).
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.
Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.