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
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.
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- 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.