Clinical trial NCT04085510: Tomosynthesis Vs. Contrast-Enhanced Mammography in Women with Personal History of Breast Cancer in Western Pennsylvania
Official title: Improving Surveillance of Women with Personal History of Breast Cancer Using Contrast-Enhanced Mammography (CEM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Breast Cancer
Breast Neoplasms
Neoplasms
Keywords: breast cancer screening
digital breast tomosynthesis
contrast-enhanced mammogram
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2019-09-11
Enrollment: 1647
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

-Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.

Exclusion Criteria:

* 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) \< 45 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.

Primary outcomes:
measure: Cancer Detection
timeFrame: 48 months
Secondary outcomes:
measure: Reader Validation
timeFrame: 48 months
Other outcomes:
Locations:
city: Cranberry Township
country: United States
facility: Magee Womancare Passavant Cranberry
state: Pennsylvania
city: Monroeville
country: United States
facility: Magee Womancare Monroeville
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Wendie Berg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: