Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis

Conditions
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Solitary Pulmonary Nodules

Intervention / Treatment
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* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Human subject specific: Not able or willing to provide Informed Consent, or consent is withdrawn.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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Predicate & Invest. DE - Human Subjects<br>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: Radiation<br>* Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. Phantoms were imaged using linear tomography and digital tomography.<br>|
| Experimental: Predicate & Invest. DT - Human Subjects<br>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: Radiation<br>* Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. Phantoms were imaged using linear tomography and digital tomography.<br>|
| Experimental: Predicate & Invest. DT - Phantom Images<br>Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational. | Radiation: Radiation<br>* Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. Phantoms were imaged using linear tomography and digital tomography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 months | 
| Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 months | 
| Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 months | 
| Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 months | 
| Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 months | 
| Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 months | 
| Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 month | 
| Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 months | 
| Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary nodule