Breast CancerNCT02386176
Assessment of Automated Breast Ultrasound
An observational study of Breast Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators are interested in assessing the value of and comparing the use of automated breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary procedure) with digital breast tomosynthesis (DBT). Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Mar 2020
- 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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women aged 40 to 75 years of age with a defined region of extremely dense breast tissue or heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts"), presenting for routine annual mammography with digital breast tomosynthesis.
Who may be able to join
- 40 to 75 years of age with a
- defined region of extremely dense breast tissue or heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts")
- presenting for routine annual mammography with digital breast tomosynthesis.
Who cannot join
- Known to be at high risk for breast cancer due to known or suspected pathologic breast cancer susceptibility gene (BRCA) (i.e. first-degree relative with known mutation) or prior chest radiation therapy before age 30;
- No mammogram within the prior 3 years;
- Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple;
- Pregnancy at the time of screening by self report or lactation within the prior 6 months;
- Breast implants, as assessment of breast density may be problematic;
- Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months;
Show all 9Show fewer
- Had prior screening with DBT and not a hand held ABUS, or had prior screening with ABUS and not DBT.
- Prior malignancy other than: Breast cancer at least one year earlier (12 full months have elapsed since the last treatment surgery) with no known distant metastases and no known residual tumor, or Basal or squamous cell skin cancer or in situ cervical cancer, or Other cancer for which the patient has been disease free for ≥ 5 years, with no recurrence of cancer in the last five years and no residual disease detected in the last five years
- Unwilling or unable to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Assessment of the Role of Automated Breast Ultrasound (ABUS) in Screening Women With Dense Breasts for Early Detection of Breast Cancer
The investigators are interested in assessing the value of and comparing the use of automated breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform a preliminary prospective study on women who are most likely to benefit from the use of ABUS and/or DBT (or a combination of both) in the screening environment.
Read the detailed description
- After appropriate training and certification of technologists and Mammography Quality Standards Act (MQSA) qualifications of the participating radiologists, the investigators will recruit sequentially approximately 600 women known to have a defined region of highly dense tissue or with known heterogeneously dense and/or primarily dense breast tissue (from a prior mammogram) who are scheduled to undergo routine mammography screening that includes a DBT examination.
- Consenting women will undergo a DBT examination as part of their routine clinical exam and an ABUS examination as a part of the experiment. All examinations will be performed by certified technologists in the performance of each of the procedures in question (DBT or ABUS).
- DBT, ABUS, and a combination of both, will be independently reviewed and interpreted (Breast Imaging, Reporting and Data System rated) by experienced and specifically trained, MQSA qualified radiologists in a cross balanced (cases by mode and by reader) study design.
- Using the results of the interpretations in a slightly modified "LOGICAL OR" mode, namely the highest rating determines the recommendation/need for follow up, the investigators will perform imaging based diagnostic work ups as needed (i.e., resulting from the "arbitration step"). All diagnostic follow up studies, as needed, will not be a part of the study protocol, with the exception of acquiring diagnostic outcome measures from medical records.
- The investigators will compare rates of false positives as a result of interpreting DBT vs. ABUS vs. a combination of both, including recall for additional testing, short-interval follow-up rates and biopsy rates. The sample in this preliminary study is too small to assess positive predictive values (PPVs), so the investigators will focus here on negative predictive values (NPVs). For marginal value assessment when utilizing both modalities, the investigators will also assess the type of abnormalities detected by each modality, assuming that a larger study will be required to assess cancer detection rates (by type etc.).
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
false positive rates
Measured: from the date interpretation until the date routine follow-up, biopsy results, or pathology results, whichever comes first, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2020
- Study completionMar 2020
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 University of PittsburghThe 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
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Denise Chough, MD, University of Pittsburgh
- Investigators
- Denise M Chough, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386176
- Sponsor's protocol ID
- PRO14110472
- Status last verified
- Apr 2020
- First submitted
- 5 Mar 2015
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Role of Automated Breast Ultrasound (ABUS) in Screening Women With Dense Breasts for Early Detection of Breast Cancer
- ClinicalTrials.gov ID
- NCT02386176
- Acronym / sponsor ID
- PRO14110472
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Aug 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 11 Mar 2015 (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.
The investigators are interested in assessing the value of and comparing the use of automated breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform a preliminary prospective study on women who are most likely to benefit from the use of ABUS and/or DBT (or a combination of both) in the screening environment.
Detailed description
- After appropriate training and certification of technologists and Mammography Quality Standards Act (MQSA) qualifications of the participating radiologists, the investigators will recruit sequentially approximately 600 women known to have a defined region of highly dense tissue or with known heterogeneously dense and/or primarily dense breast tissue (from a prior mammogram) who are scheduled to undergo routine mammography screening that includes a DBT examination.
- Consenting women will undergo a DBT examination as part of their routine clinical exam and an ABUS examination as a part of the experiment. All examinations will be performed by certified technologists in the performance of each of the procedures in question (DBT or ABUS).
- DBT, ABUS, and a combination of both, will be independently reviewed and interpreted (Breast Imaging, Reporting and Data System rated) by experienced and specifically trained, MQSA qualified radiologists in a cross balanced (cases by mode and by reader) study design.
- Using the results of the interpretations in a slightly modified "LOGICAL OR" mode, namely the highest rating determines the recommendation/need for follow up, the investigators will perform imaging based diagnostic work ups as needed (i.e., resulting from the "arbitration step"). All diagnostic follow up studies, as needed, will not be a part of the study protocol, with the exception of acquiring diagnostic outcome measures from medical records.
- The investigators will compare rates of false positives as a result of interpreting DBT vs. ABUS vs. a combination of both, including recall for additional testing, short-interval follow-up rates and biopsy rates. The sample in this preliminary study is too small to assess positive predictive values (PPVs), so the investigators will focus here on negative predictive values (NPVs). For marginal value assessment when utilizing both modalities, the investigators will also assess the type of abnormalities detected by each modality, assuming that a larger study will be required to assess cancer detection rates (by type etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 40 to 75 years of age with a defined region of extremely dense breast tissue or heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts"), presenting for routine annual mammography with digital breast tomosynthesis.
Key inclusion criteria (3 listed)
- 40 to 75 years of age with a
- defined region of extremely dense breast tissue or heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts")
- presenting for routine annual mammography with digital breast tomosynthesis.
Key exclusion criteria (9 listed)
- Known to be at high risk for breast cancer due to known or suspected pathologic breast cancer susceptibility gene (BRCA) (i.e. first-degree relative with known mutation) or prior chest radiation therapy before age 30;
- No mammogram within the prior 3 years;
- Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple;
- Pregnancy at the time of screening by self report or lactation within the prior 6 months;
- Breast implants, as assessment of breast density may be problematic;
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
false positive rates
Time frame: from the date interpretation until the date routine follow-up, biopsy results, or pathology results, whichever comes first, up to 24 months.
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 6 Apr 2020.
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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.
Denise M Chough, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Pittsburgh at 1 site in United States.
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 3 inclusion and 9 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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
false positive rates (time frame: from the date interpretation until the date routine follow-up, biopsy results, or pathology results, whichever comes first, up to 24 months.). 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 6 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.