Screening Contrast-Enhanced Mammography As an Alternative to MRI

Phase 4

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Device: Contrast-enhanced mammography; Drug: Iodinated Contrast Media (ICM)

• Registration Number: NCT04764292
• Lead Sponsor: Wendie Berg

Brief Summary

There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.

Detailed Description

This is a prospective study designed to evaluate the role of contrast enhanced mammography (CEM) in screening for breast cancer. The overarching goal of the research program is to improve cancer detection on screening, particularly in women with dense breasts. MRI depicts more cancers than other screening methods, including ultrasound. MRI is proven to both improve cancer detection and reduce clinically detected cancers ("interval cancers") after a negative screening mammogram in women with dense breasts. PA Senate Bill 595, signed into law June 30, 2020, requires insurance carriers to provide coverage for supplemental screening with MRI or ultrasound for a variety of indications. Relative to the number of women who may benefit from screening MRI, there is a shortage of equipment/capacity. Further, nearly half of women cannot have an MRI for medical or other reasons, such as claustrophobia, implanted devices, body habitus, or cost (deductible and copay apply even with the new legislation). Contrast-enhanced mammography (CEM) appears to have similar performance to MRI but has not been widely validated, particularly for screening. In order to lay the foundation for improved screening of women with dense breasts, the investigators seek to offer screening CEM as an alternative to MRI for women who meet guidelines for screening MRI but are unable to have MRI.

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 601

Inclusion Criteria

1. Asymptomatic women under age 75 who are recommended for annual screening MRI and mammography based on current criteria:

   1. Women known to be at high risk for breast cancer because of known or suspected pathogenic mutation, prior chest radiation therapy at least 8 years earlier and before age 30, or estimated lifetime risk of at least 20% based on family history/prior biopsy history (22), between age 30 and 75.
   2. Women with extremely dense breasts age 40-75 (about 7% of the screening population (1)) (12).

2. Women with lobular carcinoma in situ (1% of women biopsied each year; about 0.06% of our screening population) beginning the year after diagnosis.

3. Women with a personal history of breast cancer diagnosed by age 50 or with dense breasts (21), beginning the year after diagnosis (will be recruited under separate ongoing TOCEM protocol).

4. Women with heterogeneously dense breasts and any family history of breast cancer (about 36% of the screening population has dense breasts and about 20% have a family history of breast cancer) who do not meet current high-risk criteria, beginning at age 40 or ten years prior to the age of the youngest relative but not before age 30.

Participants are expected to have medical or other reasons that they are not able to have screening breast MRI.

Exclusion Criteria

1. Under age 30 or over age 75.
2. Pregnant or breast feeding.
3. Breast implants.
4. Breast surgery within the prior 12 months.
5. Breast signs or symptoms (lump, nipple discharge, nipple retraction, or being followed for breast abnormality on prior imaging).
6. Currently undergoing any type of systemic chemotherapy for cancer (excludes oral endocrine therapy such as aromatase inhibitors or tamoxifen).
7. Reduced kidney function with eGFR < 45 mL/min.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast-enhanced mammography	Contrast-enhanced mammography	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	Iodinated Contrast Media (ICM)	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.

Primary Outcome Measures

Name	Time	Method
Cancer Detection Rate	1.5 years	To show significantly improved cancer detection with CEM compared to standard mammography/tomosynthesis

Secondary Outcome Measures

Name	Time	Method
False Positive Recall Rates	1.5 years	To show acceptably low false positive recall rates from CEM.

Trial Locations

Locations (3)

UPMC Magee Monroeville Breast Care Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Magee at the Lemieux Sports Complex; 🇺🇸 Cranberry Township, Pennsylvania, United States

Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States