Breast CancerNCT06105749
Biennial CEM in Women With a Personal History of Breast Cancer
A study testing contrast-enhanced mammography in people with Breast Cancer and Breast Neoplasms, run by Wendie Berg at 6 sites in United States.
Trial summary
This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer. Read more about this study
- Who is it for?
- Ages 30 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- What is being tested?
- contrast-enhanced mammography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Nov 2023to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and/or treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT).
Who cannot join
- Women with a history of prior moderate or severe iodinated contrast reaction [only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded].
- Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions.
- Women who have had bilateral mastectomy
- Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 30 mL/min
- Pregnancy or lactation
- Women actively being treated for cancer of any type with chemotherapy.
Show all 9Show fewer
- Women with stage 4 metastasis to visceral areas or brain
- Women with known personal history of breast cancer who have a screening breast MRI exam within 24 months prior to the current round of CEM.
- Women with known personal history of breast cancer who had a CEM exam within the prior 23 months
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
UPMC Magee-Womens Imaging - Bethel Park
Bethel Park, Pennsylvania, 15102
McKenna Rigling, MS, 412-641-8278, riglingmm@upmc.edu
Maegan Johnson, RN, 412-641-8283, johnsonme15@upmc.edu
- Recruiting
UPMC Magee at the Lemieux Sports Complex
Cranberry Township, Pennsylvania, 16066
McKenna Rigling, MS, 412-641-8278, riglingmm@upmc.edu
Maegan Johnson, RN, 412-641-8283, johnsonme15@upmc.edu
- Recruiting
Magee Womancare Monroeville
Monroeville, Pennsylvania, 15146
McKenna Rigling, MS, 412-641-8278, riglingmm@upmc.edu
Maegan Johnson, RN, 412-641-8283, johnsonme15@upmc.edu
- Recruiting
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
McKenna Rigling, MS, 412-641-8278, riglingmm@upmc.edu
Maegan Johnson, RN, 412-641-8283, johnsonme15@upmc.edu
- Recruiting
Hillman Cancer Center at Shadyside
Pittsburgh, Pennsylvania, 15232
McKenna Rigling, MS, 412-641-8278, riglingmm@upmc.edu
Maegan Johnson, RN, 412-641-8283, johnsonme15@upmc.edu
- Recruiting
UPMC West Mifflin Outpatient Center
West Mifflin, Pennsylvania, 15236
McKenna Rigling, MS, 412-941-8278, riglingmm@upmc.edu
Maegan Johnson, RN, 412-641-8283, johnsonme15@upmc.edu
About this study
Official title: Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)
This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.
Read the detailed description
The investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (CEM) added to annual digital breast tomosynthesis (DBT) with overall fewer false positives than from annual DBT plus CEM. The investigators will offer biennial CEM exams for eligible patients. Enrolled participants will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam 24 months after their baseline CEM exam and then again at 48 months. Participants will continue to have their annual DBT exams during this time as a part of their usual care. Two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and secondary reader CEM then DBT), initially blinded to the other modality. We expect that with biennial screening, at least a similar number of cancers will be detected with CEM (and possibly more that were occult on the DBT-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (PPV1).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female, Neoplasms
- Being tested
- contrast-enhanced mammography
- Keywords
- Breast cancer screening, Digital Breast Tomosynthesis, Contrast-Enhanced Mammogram
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast-enhanced mammographyDevice
Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.
| Study group | Role | What they receive |
|---|---|---|
| contrast-enhanced mammography | Experimental | Enrolled participants will receive a baseline contrast-enhanced mammography exam for breast cancer screening, along with their scheduled 3D mammography exam, then they will receive another CEM exam for breast cancer screening at 24 months after their baseline CEM exam, and then again at 48 months. All the while, participants will still receive their annual 3D mammography exam as per their usual routine care. Receives: Device: contrast-enhanced mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cancer Detection Rate
CEM cancer detection rate for first observer vs usual care (annual DBT)
Measured: at 24 months, 48 months, and 62 months
False-positive recall rate
CEM false-positive findings for first observer vs usual care (annual DBT)
Measured: at 24 months, 48 months, and 62 months
Positive-predictive values
CEM positive-predictive values for first observer vs usual care (annual DBT)
Measured: at 24 months, 48 months, and 62 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start8 Nov 2023
- Primary completionDec 2029 (estimated)
- Study completionApr 2031 (estimated)
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.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- contrast-enhanced mammography
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wendie Berg
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- 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
- NCT06105749
- Sponsor's protocol ID
- STUDY23080183
- Status last verified
- Aug 2026
- First submitted
- 23 Oct 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Images may be shared with secondary investigators, including commercial companies after removal of all identifiers. All participant identification (name, patient number, birth date) will be removed prior to sharing.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)
- ClinicalTrials.gov ID
- NCT06105749
- Acronym / sponsor ID
- STUDY23080183
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female, Neoplasms
- Keywords
- Breast cancer screening, Digital Breast Tomosynthesis, Contrast-Enhanced Mammogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Wendie BergUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 30 Oct 2023 (actual)
- 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.
This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.
Detailed description
The investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (CEM) added to annual digital breast tomosynthesis (DBT) with overall fewer false positives than from annual DBT plus CEM. The investigators will offer biennial CEM exams for eligible patients. Enrolled participants will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam 24 months after their baseline CEM exam and then again at 48 months. Participants will continue to have their annual DBT exams during this time as a part of their usual care. Two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and secondary reader CEM then DBT), initially blinded to the other modality. We expect that with biennial screening, at least a similar number of cancers will be detected with CEM (and possibly more that were occult on the DBT-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (PPV1).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- contrast-enhanced mammography
| Arm | Type | Receives |
|---|---|---|
| contrast-enhanced mammography | Experimental | Device: contrast-enhanced mammographyEnrolled participants will receive a baseline contrast-enhanced mammography exam for breast cancer screening, along with their scheduled 3D mammography exam, then they will receive another CEM exam for breast cancer screening at 24 months after their baseline CEM exam, and then again at 48 months. All the while, participants will still receive their annual 3D mammography exam as per their usual routine care. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and/or treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT).
Key exclusion criteria (9 listed)
- Women with a history of prior moderate or severe iodinated contrast reaction [only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded].
- Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions.
- Women who have had bilateral mastectomy
- Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 30 mL/min
- Pregnancy or lactation
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 mammographyContrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion. | Device | contrast-enhanced mammography |
Primary outcome
Incremental Cancer Detection Rate
Time frame: at 24 months, 48 months, and 62 months
CEM cancer detection rate for first observer vs usual care (annual DBT)
False-positive recall rate
Time frame: at 24 months, 48 months, and 62 months
CEM false-positive findings for first observer vs usual care (annual DBT)
Positive-predictive values
Time frame: at 24 months, 48 months, and 62 months
CEM positive-predictive values for first observer vs usual care (annual DBT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Images may be shared with secondary investigators, including commercial companies after removal of all identifiers. All participant identification (name, patient number, birth date) will be removed prior to sharing.
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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.
Wendie Berg, MD, PhD principal investigator
University of Pittsburgh
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast-enhanced mammography in people with Breast Cancer and Breast Neoplasms, run by Wendie Berg at 6 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 1 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendie Berg, MD, PhD (412-641-8278, bergwa@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Cancer Detection Rate (time frame: at 24 months, 48 months, and 62 months). The study lists 3 primary outcomes in all. 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 19 Aug 2026.