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Biennial CEM in Women With a Personal History of Breast Cancer

RecruitingNA

Sponsor: Wendie Berg

Conditions: Breast Cancer, Breast Neoplasms, Breast Cancer Female, Neoplasms

Interventions: contrast-enhanced mammography

Countries: United States

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 overview

Sex: FEMALE

Age: 30 Years to 79 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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) \< 30 mL/min
* Pregnancy or lactation
* Women actively being treated for cancer of any type with chemotherapy.
* 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

Locations (6)

Bethel Park, Pennsylvania, United States
Cranberry Township, Pennsylvania, United States
Monroeville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Mifflin, Pennsylvania, United States