HealthyNCT02445287
Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)
A study testing Radiation in people with Healthy, run by Carestream Health, Inc..
Trial summary
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject 18 years or older
- Subject has provided informed consent
- Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion in the images.
- Subject(s) may have a metal screw, plate or artificial joint
Who cannot join
- Subject is pregnant
- Not able or willing to provide Informed Consent, or consent is withdrawn
- Not able to collect all required case information
- Subject has a history of high radiation exposure:
- Has undergone radiation therapy
About this study
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
Read the detailed description
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The study undertaken will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 2D imaging functionality by comparing against the predicate CARESTREAM DRX-1 GOS detector used on adult cadaver specimens to capture the image pairs.
The study will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 3D imaging functionality by comparing against the reference PHILLIPS Multi Detector Computed Tomography (MDCT) scanner used on adult cadaver specimens (body part) to capture 3D volumetric exams using the anatomy of both upper and lower extremity specimens. The adult cadaver specimens will receive multiple x-ray exposures using the predicate devices for both 2D and 3D imaging. Target images from cadaver specimens will be reviewed by radiologist readers to rate diagnostic image quality, and the data will be included in a comparative evaluation.
The live human subject portion of the study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which will receive only one 3D volumetric exam using the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) scanner. Target images will be reviewed by radiologist readers to rate diagnostic image quality according to a radiologist reader scale applicable to 3D volumetric imaging.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only.
| Study group | Role | What they receive |
|---|---|---|
| Predicate & Invest.- Cadavers 2D & 3D | Experimental | Radiation - Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Receives: Radiation: Radiation |
| Investigational - Human Subjects 3D | Experimental | Radiation - Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only. Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radlex Scale for Diagnostic Quality Ratings - 2D 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.
Measured: 12 weeks after last image capture
Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution
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.
Measured: 12 weeks after last image capture
Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK
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.
Measured: 12 weeks after last image capture
Radlex Scale for Diagnostic Quality Ratings - 3D Images SND
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.
Measured: 12 weeks after last image capture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carestream Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Marzo, MD, Principal investigator, UBMD Orthopaedics & Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445287
- Sponsor's protocol ID
- 6M3388
- Status last verified
- May 2015
- First submitted
- 11 May 2015
- Last updated
- 30 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)
- ClinicalTrials.gov ID
- NCT02445287
- Acronym / sponsor ID
- 6M3388
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Carestream Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Posted 30 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
Detailed description
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The study undertaken will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 2D imaging functionality by comparing against the predicate CARESTREAM DRX-1 GOS detector used on adult cadaver specimens to capture the image pairs.
The study will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 3D imaging functionality by comparing against the reference PHILLIPS Multi Detector Computed Tomography (MDCT) scanner used on adult cadaver specimens (body part) to capture 3D volumetric exams using the anatomy of both upper and lower extremity specimens. The adult cadaver specimens will receive multiple x-ray exposures using the predicate devices for both 2D and 3D imaging. Target images from cadaver specimens will be reviewed by radiologist readers to rate diagnostic image quality, and the data will be included in a comparative evaluation.
The live human subject portion of the study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which will receive only one 3D volumetric exam using the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) scanner. Target images will be reviewed by radiologist readers to rate diagnostic image quality according to a radiologist reader scale applicable to 3D volumetric imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predicate & Invest.- Cadavers 2D & 3D | Experimental | Radiation: RadiationRadiation - Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). |
| Investigational - Human Subjects 3D | Experimental | Radiation: RadiationRadiation - Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject 18 years or older
- Subject has provided informed consent
- Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion in the images.
- Subject(s) may have a metal screw, plate or artificial joint
Key exclusion criteria (5 listed)
- Subject is pregnant
- Not able or willing to provide Informed Consent, or consent is withdrawn
- Not able to collect all required case information
- Subject has a history of high radiation exposure:
- Has undergone radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationCadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only. | Radiation | Investigational - Human Subjects 3D, Predicate & Invest.- Cadavers 2D & 3D |
Primary outcome
Radlex Scale for Diagnostic Quality Ratings - 2D Images
Time frame: 12 weeks after last image capture
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.
Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution
Time frame: 12 weeks after last image capture
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.
Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK
Time frame: 12 weeks after last image capture
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.
Radlex Scale for Diagnostic Quality Ratings - 3D Images SND
Time frame: 12 weeks after last image capture
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Marzo, MD principal investigator
UBMD Orthopaedics & Sports Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Radiation in people with Healthy, run by Carestream Health, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radlex Scale for Diagnostic Quality Ratings - 2D Images (time frame: 12 weeks after last image capture). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.