Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
NCT ID: NCT02531646
Last Updated: 2017-03-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
66 participants
INTERVENTIONAL
2015-11-30
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion
NCT03030872
Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
NCT02478255
Evaluating New Radiation Techniques for Cardiovascular Imaging
NCT01621594
Multi-detector Computer Tomography Protocol Project: Chest Imaging Technique and Case Presentation
NCT01206751
Characteristics of Culprit Lesion and Changes in Plaque Composition. A Dual Energy Cardiac CT Study
NCT02639962
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Predicate & Invest. DE - Human Subjects
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 - 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.
Predicate & Invest. DT - Human Subjects
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 - 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.
Predicate & Invest. DT - Phantom Images
Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.
Radiation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
Not able or willing to provide Informed Consent, or consent is withdrawn. Study participant is a female of child bearing age.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Carestream Health, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Narinder Paul, MD
Role: PRINCIPAL_INVESTIGATOR
Toronto General Hospital
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9J8068
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.