Tomosynthesis Vs. Contrast-Enhanced Mammography in Women with Personal History of Breast Cancer in Western Pennsylvania

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Female; Breast Neoplasms; Neoplasms; Breast Cancer
• Interventions: Device: Contrast-enhanced mammogram

• Registration Number: NCT04085510
• Lead Sponsor: Wendie Berg

Brief Summary

This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.

Detailed Description

The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population. Participants will be invited to three rounds of annual screening with CEM. CEM must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-11
• Study Start: 2019-10-23
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-12-01
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1647

Inclusion Criteria

-Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.

Exclusion Criteria

• Women with a history of prior iodinated contrast reaction
• 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
• Lump or other breast symptoms
• Abnormality on prior breast imaging that is being followed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast-enhanced mammogram	Contrast-enhanced mammogram	All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists

Primary Outcome Measures

Name	Time	Method
Cancer Detection	48 months	Number of participants with cancer detected with contrast-enhanced mammography compared to tomosynthesis. Number of patients recalled for additional testing by each imaging test who do not have cancer (false positives). Outcomes will be assessed for both prevalence and incidence screens.

Secondary Outcome Measures

Name	Time	Method
Reader Validation	48 months	Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis.

Trial Locations

Locations (3)

Magee Womancare Monroeville; 🇺🇸 Monroeville, Pennsylvania, United States

Magee Womancare Passavant Cranberry; 🇺🇸 Cranberry Township, Pennsylvania, United States

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