Biennial contrast-enhanced mammography for women with a history of breast cancer
Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)
This study is testing if using a special type of mammogram every two years along with yearly 3D breast scans can help women with a history of breast cancer find any new cancers more effectively than just the yearly scans alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 30 Years to 79 Years |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Bethel Park, Pennsylvania and 5 other locations) |
| Trial ID | NCT06105749 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of biennial contrast-enhanced mammography (CEM) combined with annual digital breast tomosynthesis (DBT) in improving breast cancer detection rates among women with a personal history of breast cancer. Participants will undergo a baseline CEM exam alongside their routine DBT and will have follow-up CEM exams at 24 and 48 months. The study will compare the detection rates and false-positive rates of this combined approach to the standard annual DBT alone. Two radiologists will interpret the results to ensure accurate assessments.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic women aged 30-79 with a personal history of breast cancer who are at least one year post-surgery or treatment.
Not a fit: Patients who have had bilateral mastectomy, severe contrast reactions, or breast implants will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of breast cancer with fewer false-positive results for women with a history of the disease.
How similar studies have performed: Other studies have shown promise in using enhanced imaging techniques for breast cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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) \< 45 mL/min * Pregnancy or lactation * Women actively being treated for cancer of any type with chemotherapy * Having only one kidney * Women with stage 4 metastasis to visceral areas or brain * Women who have a screening breast MRI exam within 24 months prior to the current round of CEM. * Women who had a CEM exam within the prior 23 months
Where this trial is running
Bethel Park, Pennsylvania and 5 other locations
- UPMC Magee-Womens Imaging - Bethel Park — Bethel Park, Pennsylvania, United States (Recruiting)
- UPMC Magee at the Lemieux Sports Complex — Cranberry Township, Pennsylvania, United States (Recruiting)
- Magee Womancare Monroeville — Monroeville, Pennsylvania, United States (Recruiting)
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Hillman Cancer Center at Shadyside — Pittsburgh, Pennsylvania, United States (Recruiting)
- UPMC West Mifflin Outpatient Center — West Mifflin, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Wendie Berg, MD, PhD — University of Pittsburgh
- Study coordinator: Wendie Berg, MD, PhD
- Email: bergwa@upmc.edu
- Phone: 412-641-8278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.