NCT06105749 Biennial CEM in Women With a Personal History of Breast Cancer
| NCT ID | NCT06105749 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wendie Berg |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2023-11-08 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Wendie Berg, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06105749 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 79 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105749 currently recruiting?
Yes, NCT06105749 is actively recruiting participants. Contact the research team at bergwa@upmc.edu for enrollment information.
Where is the NCT06105749 trial being conducted?
This trial is being conducted at Bethel Park, United States, Cranberry Township, United States, Monroeville, United States, Pittsburgh, United States and 2 additional locations.
Who is sponsoring the NCT06105749 clinical trial?
NCT06105749 is sponsored by Wendie Berg. The principal investigator is Wendie Berg, MD, PhD at University of Pittsburgh. The trial plans to enroll 1,500 participants.
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