RECRUITING

Biennial CEM in Women with a Personal History of Breast Cancer

Conditions

Breast Cancer Breast Neoplasms Breast Cancer Female Neoplasms Breast cancer screening Digital Breast Tomosynthesis Contrast-Enhanced Mammogram

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-11-08

Study Completion:2031-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06105749

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.

Ages Eligible for Study:30 Years to 79 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Wendie Berg, MD, PhD

CONTACT

412-641-8278

bergwa@upmc.edu

McKenna Rigling, MS

CONTACT

412-641-8278

riglingmm@upmc.edu

Principal Investigator

Wendie Berg, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

UPMC Magee-Womens Imaging - Bethel Park

Bethel Park, Pennsylvania, 15102

United States

UPMC Magee at the Lemieux Sports Complex

Cranberry Township, Pennsylvania, 16066

United States

Magee Womancare Monroeville

Monroeville, Pennsylvania, 15146

United States

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

UPMC West Mifflin Outpatient Center

West Mifflin, Pennsylvania, 15236

United States

Collaborators and Investigators

Sponsor: Wendie Berg

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08

Study Completion Date2031-04

Study Record Updates

Study Start Date2023-11-08

Study Completion Date2031-04

Terms related to this study

Keywords Provided by Researchers

Breast cancer screening
Digital Breast Tomosynthesis
Contrast-Enhanced Mammogram

Additional Relevant MeSH Terms

Breast Cancer
Breast Neoplasms
Breast Cancer Female
Neoplasms