RecruitingNot ApplicableNCT06105749

Biennial CEM in Women With a Personal History of Breast Cancer

Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)

Sponsor

Wendie Berg

Enrollment

1,500 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Cancer Female Breast Neoplasms Neoplasms

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

Sex: FEMALEMin Age: 30 YearsMax Age: 79 Years

Inclusion Criteria1

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 Criteria10

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

Interventions

DEVICEcontrast-enhanced mammography

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.