Breast Cancer ScreeningNCT02310698
Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening
An observational study of Breast Cancer Screening, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- contrast enhanced digital mammography (CEDM) and whole breast screening ultrasound (WBUS)
- Type of treatment
- Medical device
- How many people
- 487 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2014to 26 Mar 2025
- 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: MSKCC clinic
Who may be able to join
- Women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other
- Women scheduled for screening CEDM alone
- Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another
Who cannot join
- Age < 30 years old
- Male patients
- Patients with any clinical breast symptoms (palpable mass, nipple discharge, etc)
- Patients with known diagnosis of breast cancer
- Patients with any breast surgery or biopsy within 90 days prior to the study
- Patients who have had a lumpectomy for breast cancer within 18 months prior to the study
- Patients who are thought to have a breast MRI within 1 year prior to the study
- Patients with contraindication to the intravenous use of iodinated contrast agent (i.e. allergy to iodinated contrast or severely impaired renal function with a creatinine level ≥1.3)
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
Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography.
Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.
- Conditions
- Breast Cancer Screening
- Being tested
- contrast enhanced digital mammography (CEDM), whole breast screening ultrasound (WBUS)
- Keywords
- Ultrasound, Enhanced Mammography, 14-240
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast enhanced digital mammography (CEDM)Device
whole breast screening ultrasound (WBUS)Device
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Screening Patients | * Women presenting for screening full field digital mammography (FFDM) and WBUS on the same day or within 30 days of one another.
o These women will be offered CEDM instead of the FFDM.
* Women that are scheduled for CEDM alone.
o These women will be offered WBUS in addition to the CEDM.
* Women scheduled for both CEDM and WBUS on the same day or within 30 days of one another. Receives: Device: contrast enhanced digital mammography (CEDM); Device: whole breast screening ultrasound (WBUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.
With respect to imaging, a positive test is defined by a recommendation for biopsy (BIRADS 4 or 5). Negative imaging tests are those with BIRADS 1-3. The number of recommendations for short term follow up (BI-RADS 3) will also be recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start2 Dec 2014
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 487 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
- NCT02310698
- Sponsor's protocol ID
- 14-240
- Status last verified
- Aug 2024
- First submitted
- 3 Dec 2014
- Last updated
- 28 Mar 2025
- Results posted
- No
Publications
Horvat JV, Amir T, Watt GP, Comstock CE, Nissan N, Jochelson MS, Sung JS. Comparison of Contrast-enhanced Mammography and Low-Energy Imaging with or without Supplemental Whole-Breast US in Breast Cancer Detection. Radiology. 2025 Mar;314(3):e242006. doi: 10.1148/radiol.242006.
PubMed 40067106
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT02310698
- Acronym / sponsor ID
- 14-240
- Conditions
- Breast Cancer Screening
- Keywords
- Ultrasound, Enhanced Mammography, 14-240
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 2 Dec 2014 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 8 Dec 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.
Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography.
Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Screening Patients | – | Device: contrast enhanced digital mammography (CEDM), Device: whole breast screening ultrasound (WBUS)* Women presenting for screening full field digital mammography (FFDM) and WBUS on the same day or within 30 days of one another. o These women will be offered CEDM instead of the FFDM. * Women that are scheduled for CEDM alone. o These women will be offered WBUS in addition to the CEDM. * Women scheduled for both CEDM and WBUS on the same day or within 30 days of one another. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinic
Key inclusion criteria (3 listed)
- Women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other
- Women scheduled for screening CEDM alone
- Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another
Key exclusion criteria (8 listed)
- Age < 30 years old
- Male patients
- Patients with any clinical breast symptoms (palpable mass, nipple discharge, etc)
- Patients with known diagnosis of breast 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 |
|---|---|---|
| contrast enhanced digital mammography (CEDM) | Device | Breast Cancer Screening Patients |
| whole breast screening ultrasound (WBUS) | Device | Breast Cancer Screening Patients |
Primary outcome
The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.
Time frame: 1 year
With respect to imaging, a positive test is defined by a recommendation for biopsy (BIRADS 4 or 5). Negative imaging tests are those with BIRADS 1-3. The number of recommendations for short term follow up (BI-RADS 3) will also be recorded.
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 28 Mar 2025.
- Derived from this study: PubMed 40067106Horvat JV, Amir T, Watt GP, Comstock CE, Nissan N, Jochelson MS, Sung JS. Comparison of Contrast-enhanced Mammography and Low-Energy Imaging with or without Supplemental Whole-Breast US in Breast Cancer Detection. Radiology. 2025 Mar;314(3):e242006. doi: 10.1148/radiol.242006.
- 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 Cancer 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 3 inclusion and 8 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 28 Mar 2025. 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?
The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310698, which also lists 1 linked publication.
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 28 Mar 2025.