Breast CancerPhase 4SCEMAMNCT04764292
Screening Contrast-Enhanced Mammography as an Alternative to MRI
A Phase 4 study testing Contrast-enhanced mammography and Iodinated Contrast Media (ICM) in people with Breast Cancer, run by Wendie Berg at 3 sites in United States.
Trial summary
There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Contrast-enhanced mammography and Iodinated Contrast Media (ICM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Feb 2021to 30 May 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria:
- Women known to be at high risk for breast cancer because of known or suspected pathogenic mutation, prior chest radiation therapy at least 8 years earlier and before age 30, or estimated lifetime risk of at least 20% based on family history/prior biopsy history (22), between age 30 and 75.
- Women with extremely dense breasts age 40-75 (about 7% of the screening population (1)) (12).
- Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis.
- Women with a personal history of breast cancer diagnosed by age 50 or with dense breasts (21), beginning the year after diagnosis (will be recruited under separate ongoing TOCEM protocol).
- Women with heterogeneously dense breasts and any family history of breast cancer (about 36% of the screening population has dense breasts and about 20% have a family history of breast cancer) who do not meet current high-risk criteria, beginning at age 40 or ten years prior to the age of the youngest relative but not before age 30.
- Participants are expected to have medical or other reasons that they are not able to have screening breast MRI.
Who cannot join
- Under age 30 or over age 75.
- Pregnant or breast feeding.
- Breast implants.
- Breast surgery within the prior 12 months.
- Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging).
- Currently undergoing any type of systemic chemotherapy for cancer (excludes oral endocrine therapy such as aromatase inhibitors or tamoxifen).
- Reduced kidney function with eGFR < 45 mL/min.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UPMC Magee at the Lemieux Sports Complex
Cranberry Township, Pennsylvania, 16066
UPMC Magee Monroeville Breast Care Center
Pittsburgh, Pennsylvania, 15146
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.
Read the detailed description
This is a prospective study designed to evaluate the role of contrast enhanced mammography (CEM) in screening for breast cancer. The overarching goal of the research program is to improve cancer detection on screening, particularly in women with dense breasts. MRI depicts more cancers than other screening methods, including ultrasound. MRI is proven to both improve cancer detection and reduce clinically detected cancers ("interval cancers") after a negative screening mammogram in women with dense breasts. PA Senate Bill 595, signed into law June 30, 2020, requires insurance carriers to provide coverage for supplemental screening with MRI or ultrasound for a variety of indications. Relative to the number of women who may benefit from screening MRI, there is a shortage of equipment/capacity. Further, nearly half of women cannot have an MRI for medical or other reasons, such as claustrophobia, implanted devices, body habitus, or cost (deductible and copay apply even with the new legislation). Contrast-enhanced mammography (CEM) appears to have similar performance to MRI but has not been widely validated, particularly for screening. In order to lay the foundation for improved screening of women with dense breasts, the investigators seek to offer screening CEM as an alternative to MRI for women who meet guidelines for screening MRI but are unable to have MRI.
- Conditions
- Breast Cancer
- Being tested
- Contrast-enhanced mammography, Iodinated Contrast Media (ICM)
- Keywords
- breast cancer supplemental screening, breast density, contrast-enhanced mammography, screening mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced mammographyDevice
supplemental breast cancer screening with contrast-enhanced mammography
Iodinated Contrast Media (ICM)Drug
supplemental breast cancer screening with contrast-enhanced mammography
| Study group | Role | What they receive |
|---|---|---|
| Contrast-enhanced mammography | Experimental | Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice. Receives: Device: Contrast-enhanced mammography; Drug: Iodinated Contrast Media (ICM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection Rate (CDR) Per 1,000 Screenings
Cancer detection rate per 1,000 screenings with CEM compared to standard mammography/tomosynthesis (DBT) alone. Interpretation and performance outcomes from the primary reader were compared between standard-of-care DBT examinations interpreted alone and DBT examinations interpreted with the addition of CEM.
Measured: 1.5 years
Secondary outcomes (3)
False Positive Recall Rates
To assess changes in false positive recall rates from CEM. DBT false-positive findings for primary observer (usual care) vs DBT and CEM false positive findings for primary observer
Measured: 1.5 years
Biopsy Rate
To assess changes in the biopsy rate after the addition of CEM. DBT biopsy rate for primary observer (usual care) vs DBT and CEM biopsy rate for primary observer.
Measured: 1.5 years
Positive Predictive Value of Recall (PPV1)
To assess changes in positive predictive value of recall (PPV1) after the addition of CEM. DBT PPV1for primary observer (usual care) vs DBT and CEM PPV1 for primary observer.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Feb 2021
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wendie Berg
- Sponsor type
- University, hospital or other
- Collaborators
- PA Breast Cancer Coalition
- Responsible party
- Sponsor-investigator, Wendie Berg, University of Pittsburgh
- Investigators
- Wendie Berg, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764292
- Sponsor's protocol ID
- STUDY20110029
- Acronym
- SCEMAM
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2021
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Images may be shared with secondary investigators, including commercial companies after removal of all identifiers. All patient identification (name, patient number, birth date) will be removed from the DICOM headers of the images.
Publications
Berg WA, Vargo A, Lu AH, Berg JM, Bandos AI, Hartman JY, Zuley ML, Ganott MA, Kelly AE, Nair BE, Chough DM, Reginella RF, Wallace LP, Harnist KS, Carlin BA, Cohen CS, Hakim CM, Sumkin JH. Screening for Breast Cancer with Contrast-enhanced Mammography as an Alternative to MRI: SCEMAM Trial Results. Radiology. 2025 Jun;315(3):e242634. doi: 10.1148/radiol.242634.
PubMed 40525975
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Contrast-Enhanced Mammography as an Alternative to MRI
- ClinicalTrials.gov ID
- NCT04764292
- Acronym / sponsor ID
- SCEMAM / STUDY20110029
- Conditions
- Breast Cancer
- Keywords
- breast cancer supplemental screening, breast density, contrast-enhanced mammography, screening mammography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Wendie BergUniversity, hospital or other
- Collaborators
- PA Breast Cancer Coalition
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.
Detailed description
This is a prospective study designed to evaluate the role of contrast enhanced mammography (CEM) in screening for breast cancer. The overarching goal of the research program is to improve cancer detection on screening, particularly in women with dense breasts. MRI depicts more cancers than other screening methods, including ultrasound. MRI is proven to both improve cancer detection and reduce clinically detected cancers ("interval cancers") after a negative screening mammogram in women with dense breasts. PA Senate Bill 595, signed into law June 30, 2020, requires insurance carriers to provide coverage for supplemental screening with MRI or ultrasound for a variety of indications. Relative to the number of women who may benefit from screening MRI, there is a shortage of equipment/capacity. Further, nearly half of women cannot have an MRI for medical or other reasons, such as claustrophobia, implanted devices, body habitus, or cost (deductible and copay apply even with the new legislation). Contrast-enhanced mammography (CEM) appears to have similar performance to MRI but has not been widely validated, particularly for screening. In order to lay the foundation for improved screening of women with dense breasts, the investigators seek to offer screening CEM as an alternative to MRI for women who meet guidelines for screening MRI but are unable to have MRI.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced mammography | Experimental | Device: Contrast-enhanced mammography, Drug: Iodinated Contrast Media (ICM)Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria:
- Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis.
- Women with a personal history of breast cancer diagnosed by age 50 or with dense breasts (21), beginning the year after diagnosis (will be recruited under separate ongoing TOCEM protocol).
- Women with heterogeneously dense breasts and any family history of breast cancer (about 36% of the screening population has dense breasts and about 20% have a family history of breast cancer) who do not meet current high-risk criteria, beginning at age 40 or ten years prior to the age of the youngest relative but not before age 30.
- Participants are expected to have medical or other reasons that they are not able to have screening breast MRI.
Key exclusion criteria (7 listed)
- Under age 30 or over age 75.
- Pregnant or breast feeding.
- Breast implants.
- Breast surgery within the prior 12 months.
- Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging).
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 mammographysupplemental breast cancer screening with contrast-enhanced mammography | Device | Contrast-enhanced mammography |
| Iodinated Contrast Media (ICM)supplemental breast cancer screening with contrast-enhanced mammography | Drug | Contrast-enhanced mammography |
Primary outcome
Cancer Detection Rate (CDR) Per 1,000 Screenings
Time frame: 1.5 years
Cancer detection rate per 1,000 screenings with CEM compared to standard mammography/tomosynthesis (DBT) alone. Interpretation and performance outcomes from the primary reader were compared between standard-of-care DBT examinations interpreted alone and DBT examinations interpreted with the addition of CEM.
3 secondary outcomes
False Positive Recall Rates
Time frame: 1.5 years
Biopsy Rate
Time frame: 1.5 years
Positive Predictive Value of Recall (PPV1)
Time frame: 1.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40525975Berg WA, Vargo A, Lu AH, Berg JM, Bandos AI, Hartman JY, Zuley ML, Ganott MA, Kelly AE, Nair BE, Chough DM, Reginella RF, Wallace LP, Harnist KS, Carlin BA, Cohen CS, Hakim CM, Sumkin JH. Screening for Breast Cancer with Contrast-enhanced Mammography as an Alternative to MRI: SCEMAM Trial Results. Radiology. 2025 Jun;315(3):e242634. doi: 10.1148/radiol.242634.
- Individual participant dataSharing planned: Yes. Images may be shared with secondary investigators, including commercial companies after removal of all identifiers. All patient identification (name, patient number, birth date) will be removed from the DICOM headers of the images.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Wendie Berg, MD, PhD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contrast-enhanced mammography and Iodinated Contrast Media (ICM) in people with Breast Cancer, run by Wendie Berg at 3 sites 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 7 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cancer Detection Rate (CDR) Per 1,000 Screenings (time frame: 1.5 years). 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 NCT04764292, 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 22 May 2026.