Breast NeoplasmsNCT02864667
Reader Study for Image Quality of Cone Beam Breast CT System
An observational study of Breast Neoplasms, run by Koning Corporation.
Trial summary
Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: It is reported that digital mammography has reject rate between 8% and 10% and positioning is the major reason of rejection [1]. In order to prove that the KBCT detector/table is able to provide correct position and sufficient image quality to achieve equal or lower rejection rate than mammography, a minimum number of 10 cases is required.
Who may be able to join
- Females at least 35 years of age of any ethnicity
- Had a mammogram, read as BIRADS 1 or 2 (group I) or BIRADS 4 or 5 (group II)
- Will undergo study imaging no later than four weeks from date of mammogram
- Is able to undergo informed consent
- Require diagnostic imaging
Who cannot join
- Pregnancy
- Lactation
- Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
- Subjects who are unable to tolerate study constraints
- Subjects who are unable to tolerate study constraints
- Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
Show all 11Show fewer
- Treatment for enlarged thymus gland as an infant
- Irradiation for benign breast conditions, including breast inflammation after giving birth
- Treatment for Hodgkin's disease
- Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram
- Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) Tuberculosis Severe scoliosis
About this study
Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.
The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.
Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.
Read the detailed description
Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.
The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.
Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.
Images from ten (10) female patients (cases) with different breast sizes will be evaluated by 3 independent board-certified, MQSA-qualified radiologists (readers). The images were acquired from a separate clinical trial using KBCT system with the new table/detector.
Two readers will independently evaluate the image quality of each case and choose to "accept" or "reject" the case. If there is a disagreement for a certain case, a third reader will independently evaluate that case and give the final result.
- Conditions
- Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Rejection Rate
Measured: One hour training session followed by a one hour reading session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koning Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864667
- Sponsor's protocol ID
- 16-02
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reader Study for Image Quality of Cone Beam Breast CT System
- ClinicalTrials.gov ID
- NCT02864667
- Acronym / sponsor ID
- 16-02
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Koning CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.
The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.
Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.
Detailed description
Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.
The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.
Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.
Images from ten (10) female patients (cases) with different breast sizes will be evaluated by 3 independent board-certified, MQSA-qualified radiologists (readers). The images were acquired from a separate clinical trial using KBCT system with the new table/detector.
Two readers will independently evaluate the image quality of each case and choose to "accept" or "reject" the case. If there is a disagreement for a certain case, a third reader will independently evaluate that case and give the final result.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is reported that digital mammography has reject rate between 8% and 10% and positioning is the major reason of rejection [1]. In order to prove that the KBCT detector/table is able to provide correct position and sufficient image quality to achieve equal or lower rejection rate than mammography, a minimum number of 10 cases is required.
Key inclusion criteria (5 listed)
- Females at least 35 years of age of any ethnicity
- Had a mammogram, read as BIRADS 1 or 2 (group I) or BIRADS 4 or 5 (group II)
- Will undergo study imaging no later than four weeks from date of mammogram
- Is able to undergo informed consent
- Require diagnostic imaging
Key exclusion criteria (11 listed)
- Pregnancy
- Lactation
- Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
- Subjects who are unable to tolerate study constraints
- Subjects who are unable to tolerate study constraints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rejection Rate
Time frame: One hour training session followed by a one hour reading session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Koning Corporation.
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 5 inclusion and 11 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 12 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rejection Rate (time frame: One hour training session followed by a one hour reading session). 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 12 Aug 2016.