Breast Cancer FemaleTOCEMNCT04085510
Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania
A study testing Contrast-enhanced mammogram in people with Breast Cancer Female and Breast Cancer, run by Wendie Berg at 3 sites in United States.
Trial summary
This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, 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 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Breast Cancer, Breast Neoplasms
- What is being tested?
- Contrast-enhanced mammogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,647 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Oct 2019to 30 Dec 2028
- 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 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.
Who cannot join
- Women with a history of prior iodinated contrast reaction
- 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
- Lump or other breast symptoms
- Abnormality on prior breast imaging that is being followed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Magee Womancare Passavant Cranberry
Cranberry Township, Pennsylvania, 16066
Magee Womancare Monroeville
Monroeville, Pennsylvania, 15146
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Improving Surveillance of Women With Personal History of Breast Cancer Using Contrast-Enhanced Mammography (CEM)
This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.
Read the detailed description
The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population. Participants will be invited to three rounds of annual screening with CEM. CEM must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Neoplasms, Neoplasms
- Being tested
- Contrast-enhanced mammogram
- 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 mammogramDevice
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 mammogram | Experimental | All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists Receives: Device: Contrast-enhanced mammogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection
Number of participants with cancer detected with contrast-enhanced mammography compared to tomosynthesis. Number of patients recalled for additional testing by each imaging test who do not have cancer (false positives). Outcomes will be assessed for both prevalence and incidence screens.
Measured: 48 months
Secondary outcomes (1)
Reader Validation
Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start23 Oct 2019
- Primary completion10 Sep 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Masking
- None (open label)
- Enrolment
- 1,647 participants (actual)
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
- NCT04085510
- Sponsor's protocol ID
- STUDY19060359
- Acronym
- TOCEM
- Status last verified
- Mar 2026
- First submitted
- 6 Sep 2019
- Last updated
- 9 Mar 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.