- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02531646
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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Not able or willing to provide Informed Consent, or consent is withdrawn.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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 - 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.
|
Experimental: 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 - 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.
|
Experimental: 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 - 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 month
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Narinder Paul, MD, Toronto General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9J8068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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