Breast CancerNCT01593384
Prospective Chart-Review: Impact of Combination - Digital Breast Tomosynthesis + Digital Mammography
An observational study of Breast Cancer, run by Case Comprehensive Cancer Center.
Trial summary
Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion detection in dense breasted women. Even though DBT has been regarded as a study for dense breasted women, it may also improve lesion detection at an earlier stage and smaller size in women with less dense breast tissue. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Feb 2013
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects from routine clinical patient population at our medical facility. There will be inclusion of employees and students in the study. A number of UHCMC employees and a few CWRU students are in our routine clinical patient population.
Who may be able to join
- Female ages 30 and over
- Asymptomatic
- Any ethnic origin
- No contraindication for routine bilateral mammogram
Who cannot join
- Pregnancy
- Lactating patients
- Breast implants
- Unable to understand and execute written informed consent
- Patient unable to obtain a mammogram while standing without assistance
About this study
Official title: To Determine the Clinical Impact of the Combination of Digital Breast Tomosynthesis and Digital Mammography on Screening for Breast Cancer
Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion detection in dense breasted women. Even though DBT has been regarded as a study for dense breasted women, it may also improve lesion detection at an earlier stage and smaller size in women with less dense breast tissue. The overlapping of tissue on a standard of care 2D mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that mimic cancers. This leads to patients being asked to come back for additional imaging including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by up to 43% in reader studies. Even though these results are promising they were not done in a realistic clinical setting.The purpose of this study is to evaluate the FDA-approved combination standard digital mammography (DM) and DBT technology and its impact on our clinical practice.
Read the detailed description
The investigators would like to prospectively measure the impact on recall rates, comparing DM (digital mammography) and DM+DBT, in our practice and the impact on cancer detection in our screening population. This is a two-site study in which all asymptomatic subjects undergoing the FDA-approved combination standard of care Digital Mammogram and Digital Breast Tomosynthesis (DM+DBT) exam will be eligible for the trial. Each subject will be her own control.Only radiologists who have gone through 8 hours of Tomosynthesis training will interpret the DM and DBT images. These radiologists will categorize each case as either dense (BI-RADS density score of 3 or 4) or fatty (BI-RADS density score of 1 or 2). The radiologist will initially read the standard of care DM part of the study first and record their interpretation and final BIRADs category. The same radiologist will then interpret the DM+DBT combination study and record their final interpretation and BIRADs category. Prior mammogram studies will be used for comparison when reading the DM and DM+DBT studies.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Digital Breast Tomosynthesis (DBT), Digital Mammography (DM)
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the impact on recall rates, comparing DM and DM+DBT
Measure the impact on recall rates, comparing DM and DM+DBT, in our practice and the impact on cancer detection in our screening population.
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Plecha, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593384
- Sponsor's protocol ID
- CASE2112
- Status last verified
- Feb 2016
- First submitted
- 4 May 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Clinical Impact of the Combination of Digital Breast Tomosynthesis and Digital Mammography on Screening for Breast Cancer
- ClinicalTrials.gov ID
- NCT01593384
- Acronym / sponsor ID
- CASE2112
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Digital Breast Tomosynthesis (DBT), Digital Mammography (DM)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (actual)
- First posted
- 8 May 2012 (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.
Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion detection in dense breasted women. Even though DBT has been regarded as a study for dense breasted women, it may also improve lesion detection at an earlier stage and smaller size in women with less dense breast tissue. The overlapping of tissue on a standard of care 2D mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that mimic cancers. This leads to patients being asked to come back for additional imaging including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by up to 43% in reader studies. Even though these results are promising they were not done in a realistic clinical setting.The purpose of this study is to evaluate the FDA-approved combination standard digital mammography (DM) and DBT technology and its impact on our clinical practice.
Detailed description
The investigators would like to prospectively measure the impact on recall rates, comparing DM (digital mammography) and DM+DBT, in our practice and the impact on cancer detection in our screening population. This is a two-site study in which all asymptomatic subjects undergoing the FDA-approved combination standard of care Digital Mammogram and Digital Breast Tomosynthesis (DM+DBT) exam will be eligible for the trial. Each subject will be her own control.Only radiologists who have gone through 8 hours of Tomosynthesis training will interpret the DM and DBT images. These radiologists will categorize each case as either dense (BI-RADS density score of 3 or 4) or fatty (BI-RADS density score of 1 or 2). The radiologist will initially read the standard of care DM part of the study first and record their interpretation and final BIRADs category. The same radiologist will then interpret the DM+DBT combination study and record their final interpretation and BIRADs category. Prior mammogram studies will be used for comparison when reading the DM and DM+DBT studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects from routine clinical patient population at our medical facility. There will be inclusion of employees and students in the study. A number of UHCMC employees and a few CWRU students are in our routine clinical patient population.
Key inclusion criteria (4 listed)
- Female ages 30 and over
- Asymptomatic
- Any ethnic origin
- No contraindication for routine bilateral mammogram
Key exclusion criteria (5 listed)
- Pregnancy
- Lactating patients
- Breast implants
- Unable to understand and execute written informed consent
- Patient unable to obtain a mammogram while standing without assistance
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
Measure the impact on recall rates, comparing DM and DM+DBT
Time frame: 3 yrs
Measure the impact on recall rates, comparing DM and DM+DBT, in our practice and the impact on cancer detection in our screening population.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
Donna Plecha, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Case Comprehensive Cancer Center.
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: withdrawn, as of the sponsor's last update on 17 Feb 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 was withdrawn before enrolling participants, so there are no results.
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?
Measure the impact on recall rates, comparing DM and DM+DBT (time frame: 3 yrs). 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 17 Feb 2016.