Contrast-Enhanced Mammography for Breast Cancer Screening

(SCEMAM Trial)

Recruiting at 2 trial locations

Overseen by Wendie Berg, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Wendie Berg

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing contrast-enhanced mammography (CEM) as an alternative for women who need a breast MRI but can't get one. CEM uses a special dye with regular mammogram machines to make cancer spots more visible. The goal is to improve breast cancer detection in women who can't have an MRI. CEM combines conventional mammography with iodinated contrast material to improve cancer detection.

Research Team

Wendie Berg, MD, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for women aged 30-75 with dense breasts or high breast cancer risk due to genetics, family history, or past chest radiation. It's also for those recommended for MRI screening but can't have it due to factors like claustrophobia or implants. Women with a personal history of early breast cancer are eligible too. Exclusions include current breast symptoms, poor kidney function, active chemotherapy (except oral endocrine therapy), having breast implants, being under 30 or over 75 years old, and recent pregnancy/breastfeeding or breast surgery.

Inclusion Criteria

Women aged 40-75 with very dense breasts.

You have a high risk of breast cancer due to genetic mutations, past radiation therapy to the chest before the age of 30, or a strong family history of breast cancer.

Women under 75 years old who are advised to have yearly MRI and mammogram screenings based on current guidelines.

Exclusion Criteria

You have noticeable breast changes like a lump, nipple discharge, or nipple retraction, or you have been getting checked for a breast abnormality.

Your kidneys are not working well, with an eGFR less than 45 mL/min.

You are currently receiving treatment for cancer with chemotherapy, but not with oral hormone therapy like aromatase inhibitors or tamoxifen.

Treatment Details

Interventions

• Contrast-enhanced mammography (Procedure)
• Iodinated Contrast Media (ICM) (Contrast Media)

Trial Overview The study tests if contrast-enhanced mammography (CEM) can be an alternative to MRI for breast cancer screening in women who cannot undergo MRI. CEM uses standard mammography equipment plus an intravenous iodinated contrast agent similar to what's used in CT scans.

Participant Groups

Group I: Contrast-enhanced mammography Experimental Treatment 2 Interventions

Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.

Contrast-enhanced mammography is already approved in Canada for the following indications:

Approved in Canada as CEM for:

• Breast cancer screening in women with dense breasts or high risk
• Preoperative staging of breast cancer
• Monitoring response to neoadjuvant chemotherapy

Who Is Running the Clinical Trial?

Wendie Berg

Lead Sponsor

Trials

4

Recruited

10,000+

PA Breast Cancer Coalition

Collaborator

Trials

1

Recruited

600+