Biennial CEM in Women with a Personal History of Breast Cancer

Description

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.

Conditions

Breast Cancer, Breast Neoplasms, Breast Cancer Female, Neoplasms

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Study Overview

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Study Details

Study overview

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.

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

Biennial CEM in Women with a Personal History of Breast Cancer

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Bethel Park

UPMC Magee-Womens Imaging - Bethel Park, Bethel Park, Pennsylvania, United States, 15102

Cranberry Township

UPMC Magee at the Lemieux Sports Complex, Cranberry Township, Pennsylvania, United States, 16066

Monroeville

Magee Womancare Monroeville, Monroeville, Pennsylvania, United States, 15146

Pittsburgh

Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States, 15213

West Mifflin

UPMC West Mifflin Outpatient Center, West Mifflin, Pennsylvania, United States, 15236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

30 Years to 79 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Wendie Berg,

Wendie Berg, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2031-04