Breast ScreeningNCT02174406
Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
An observational study of Breast Screening, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Screening
- What is being tested?
- breast ultrasound and DBT (Full field digital mammography + tomosynthesis)
- Type of treatment
- Surgery or procedure
- How many people
- 1,494 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2014to 19 Jan 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All women scheduled for a WBUS and a FFDM on the same day or within the following 30 days of each other will be identified by the investigators/research staff at MSKCC clinic.
Who may be able to join
- Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other.
Who cannot join
- Age < 30 years old
- Male patients
- Patients with any clinical symptoms (palpable mass, nipple discharge, etc)
- Patients with known cancer
- Patients with any breast surgery or biopsy within 90 days prior to the study
- Patients with breast implants
- Patients pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.
- Conditions
- Breast Screening
- Being tested
- breast ultrasound, DBT (Full field digital mammography + tomosynthesis)
- Keywords
- Ultrasound, Digital Breast Tomosynthesis, 14-119
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast ultrasoundProcedure or surgery
DBT (Full field digital mammography + tomosynthesis)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| women scheduled for breast screening | Each patient will have the following:
* Screening whole breast ultrasound
* DBT (Full field digital mammography + tomosynthesis views in the CC and MLO projections). The only change in patient management will be the addition of digital breast tomosynthesis views in patients scheduled for FFDM alone. DBT is currently clinically approved and being offered on a voluntary basis to patients scheduled for FFDM. Receives: Procedure: breast ultrasound; Procedure: DBT (Full field digital mammography + tomosynthesis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the cancer detection rates
The detection rate of each imaging test is defined as the proportion of patients who are positive on that imaging test who truly have the disease compared to the total number of women screened. A positive imaging test is defined as a test with a recommendation for biopsy (BI-RADS 4 or 5).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study start23 Jun 2014
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ScreeningStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Sung, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174406
- Sponsor's protocol ID
- 14-119
- Status last verified
- Jan 2023
- First submitted
- 23 Jun 2014
- Last updated
- 23 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
- ClinicalTrials.gov ID
- NCT02174406
- Acronym / sponsor ID
- 14-119
- Conditions
- Breast Screening
- Keywords
- Ultrasound, Digital Breast Tomosynthesis, 14-119
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,494 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 25 Jun 2014 (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 purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women scheduled for breast screening | – | Procedure: breast ultrasound, Procedure: DBT (Full field digital mammography + tomosynthesis)Each patient will have the following: * Screening whole breast ultrasound * DBT (Full field digital mammography + tomosynthesis views in the CC and MLO projections). The only change in patient management will be the addition of digital breast tomosynthesis views in patients scheduled for FFDM alone. DBT is currently clinically approved and being offered on a voluntary basis to patients scheduled for FFDM. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women scheduled for a WBUS and a FFDM on the same day or within the following 30 days of each other will be identified by the investigators/research staff at MSKCC clinic.
Key inclusion criteria (1 listed)
- Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other.
Key exclusion criteria (7 listed)
- Age < 30 years old
- Male patients
- Patients with any clinical symptoms (palpable mass, nipple discharge, etc)
- Patients with known cancer
- Patients with any breast surgery or biopsy within 90 days prior to the study
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 |
|---|---|---|
| breast ultrasound | Procedure or surgery | women scheduled for breast screening |
| DBT (Full field digital mammography + tomosynthesis) | Procedure or surgery | women scheduled for breast screening |
Primary outcome
estimate the cancer detection rates
Time frame: 2 years
The detection rate of each imaging test is defined as the proportion of patients who are positive on that imaging test who truly have the disease compared to the total number of women screened. A positive imaging test is defined as a test with a recommendation for biopsy (BI-RADS 4 or 5).
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 23 Jan 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Janice Sung, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Screening, run by Memorial Sloan Kettering Cancer Center 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 1 inclusion and 7 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 23 Jan 2023. 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?
estimate the cancer detection rates (time frame: 2 years). 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 23 Jan 2023.