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

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

Plain Language Summary

Simplified for easier understanding

This trial is comparing contrast-enhanced mammography (CEM) to standard 3D mammography (tomosynthesis) in women who have previously had breast cancer, to see whether CEM catches more cancers and reduces unnecessary procedures. **You may be eligible if...** - You are a woman aged 30–79 with a personal history of breast cancer - It has been at least one year since your last breast surgery or treatment - You are scheduled for a routine annual mammogram - You have not had a screening breast MRI within the past 24 months **You may NOT be eligible if...** - You have a history of moderate or severe iodinated contrast reaction (mild reactions may be manageable with premedication) - You have breast implants in the breasts to be screened - You have had a bilateral mastectomy - Your kidney function is significantly reduced (eGFR below 45) or you have only one kidney - You are pregnant or breastfeeding - You are currently receiving chemotherapy for any cancer - You have stage 4 cancer with spread to organs or brain - You have had a CEM exam within the prior 23 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(6)

UPMC Magee-Womens Imaging - Bethel Park

Bethel Park, Pennsylvania, United States

UPMC Magee at the Lemieux Sports Complex

Cranberry Township, Pennsylvania, United States

Magee Womancare Monroeville

Monroeville, Pennsylvania, United States

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Hillman Cancer Center at Shadyside

Pittsburgh, Pennsylvania, United States

UPMC West Mifflin Outpatient Center

West Mifflin, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06105749


Related Trials