Breast Cancer DiagnosisNCT01952717
PMA Required Pivotal Multi-reader Multi-case Reader Study
An observational study of Breast Cancer Diagnosis, run by Koning Corporation.
Trial summary
A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer Diagnosis
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Mar 2014
- 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: This study will involve 18 readers reading and scoring the conventional 2D diagnostic mammograms and the 3D KBCT images of 236 cases.
Who may be able to join
- At least 40 or 35 years of age of any ethnicity Had a routine mammogram, read as BI-RADS® 3 Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality After diagnostic work-up are categorized as BI-RADS® 4 or 5. Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
- Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up Is able to provide informed consent
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 have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) Treatment for enlarged thymus gland as an infant Irradiation for benign breast conditions, including breast inflammation after giving birth Treatment for Hodgkins 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
Official title: A Multi-Reader Multi-Case Clinical Trial To Evaluate Diagnostic Accuracy of 3D Koning Breast CT Compared to 2D Diagnostic Mammography
A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA).
Read the detailed description
This study will be conducted according to US and international standards of Good Clinical Practice (FDA regulations 21 CFR 11, 50, 56, and 812 and FDA guidance E6). Applicable government regulations and Medical University of South Carolina research policies and procedures will also be followed.
The goal of the study is to evaluate if 3D KBCT can improve the clinical performance of diagnostic workup for breast cancer detection and diagnosis compared to 2D Diagnostic Mammography.
This study will involve 18 readers reading and scoring the conventional 2D diagnostic mammograms and the 3D KBCT images of 236 cases. Each reader will undergo one day of training prior to beginning the reader study. The reader study will be broken up into one three-day reading session (includes training day) and three two-day reading sessions with a washout period of at least four weeks in between sessions.
The 2D diagnostic mammograms include standard 2-view mammograms and any additional diagnostic views. The ROC curves will be constructed for 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO) (screening or diagnostic), and 3D KBCT. The area under the ROC curve (AUC) will be compared. The clinical decision regarding biopsy will also be evaluated by estimating the sensitivity and specificity of 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO), and 3D KBCT.
This study, including the training of the participating radiologists, will be conducted at the Department of Radiology at Medical University of South Carolina.
- Conditions
- Breast Cancer Diagnosis
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Receiver Operating Characteristics Curve (AUC)
The 2D diagnostic mammograms include standard 2-view mammograms and any additional diagnostic views. The ROC curves will be constructed for 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO) (screening or diagnostic), and 3D KBCT. The area under the ROC curve (AUC) will be compared.
Measured: one three-day reading session (includes training day) and three two-day reading sessions with a washout period of at least four weeks in between sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DiagnosisStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 236 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
- NCT01952717
- Sponsor's protocol ID
- KBCT-006
- Status last verified
- Mar 2015
- First submitted
- 24 Sep 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Reader Multi-Case Clinical Trial To Evaluate Diagnostic Accuracy of 3D Koning Breast CT Compared to 2D Diagnostic Mammography
- ClinicalTrials.gov ID
- NCT01952717
- Acronym / sponsor ID
- KBCT-006
- Conditions
- Breast Cancer Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Koning CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Sep 2013 (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.
A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA).
Detailed description
This study will be conducted according to US and international standards of Good Clinical Practice (FDA regulations 21 CFR 11, 50, 56, and 812 and FDA guidance E6). Applicable government regulations and Medical University of South Carolina research policies and procedures will also be followed.
The goal of the study is to evaluate if 3D KBCT can improve the clinical performance of diagnostic workup for breast cancer detection and diagnosis compared to 2D Diagnostic Mammography.
This study will involve 18 readers reading and scoring the conventional 2D diagnostic mammograms and the 3D KBCT images of 236 cases. Each reader will undergo one day of training prior to beginning the reader study. The reader study will be broken up into one three-day reading session (includes training day) and three two-day reading sessions with a washout period of at least four weeks in between sessions.
The 2D diagnostic mammograms include standard 2-view mammograms and any additional diagnostic views. The ROC curves will be constructed for 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO) (screening or diagnostic), and 3D KBCT. The area under the ROC curve (AUC) will be compared. The clinical decision regarding biopsy will also be evaluated by estimating the sensitivity and specificity of 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO), and 3D KBCT.
This study, including the training of the participating radiologists, will be conducted at the Department of Radiology at Medical University of South Carolina.
Study design
- Observational model
- Case-control
- 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
- This study will involve 18 readers reading and scoring the conventional 2D diagnostic mammograms and the 3D KBCT images of 236 cases.
Key inclusion criteria (2 listed)
- At least 40 or 35 years of age of any ethnicity Had a routine mammogram, read as BI-RADS® 3 Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality After diagnostic work-up are categorized as BI-RADS® 4 or 5. Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
- Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up Is able to provide informed consent
Key exclusion criteria (1 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 have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) Treatment for enlarged thymus gland as an infant Irradiation for benign breast conditions, including breast inflammation after giving birth Treatment for Hodgkins 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
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
Area under the Receiver Operating Characteristics Curve (AUC)
Time frame: one three-day reading session (includes training day) and three two-day reading sessions with a washout period of at least four weeks in between sessions
The 2D diagnostic mammograms include standard 2-view mammograms and any additional diagnostic views. The ROC curves will be constructed for 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO) (screening or diagnostic), and 3D KBCT. The area under the ROC curve (AUC) will be compared.
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 11 Mar 2015.
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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 Cancer Diagnosis, 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 2 inclusion and 1 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 11 Mar 2015. 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?
Area under the Receiver Operating Characteristics Curve (AUC) (time frame: one three-day reading session (includes training day) and three two-day reading sessions with a washout period of at least four weeks in between sessions). 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 11 Mar 2015.