Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis

Solitary Pulmonary Nodules Clinical Trial

Official title:

Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02531646
• Other study ID #: 9J8068
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 20, 2015
• Last updated: February 19, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2015
• Source: Carestream Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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Not able or willing to provide Informed Consent, or consent is withdrawn.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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule
• Solitary Pulmonary Nodules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carestream Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duel Energy	The imaging performance of the investigational DE software (SW) will be evaluated on exams from 30-40 patients. A Reader Study will be conducted with these images using the RadLex Scale to rate the images, 1-Non-diagnostic, 2-Limited, 3-Diagnostic, 4-Exemplary.	3 months	No
Secondary	Digital Tomography Images	The tomographic imaging performance of the investigational DT SW will be evaluated on exams from 15-20 patients. A Reader Study will be conducted with these images using the RadLex Scale to rate the images, 1-Non-diagnostic, 2-Limited, 3-Diagnostic, 4-Exemplary.	3 months	No