NCT03929783

Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.

Detailed description

PRIMARY OBJECTIVES: I. To obtain preliminary data to support the hypothesis that contrast enhanced mammography (CEM) can reduce benign tissue diagnosis (FP3) and therefore improve positive predictive value 3 (PPV3). SECONDARY OBJECTIVES: I. Identify specific CEM characteristics that accurately classify a finding as benign, high-risk or malignant. II. Assess the positive and negative predictive values for each digital breast tomosynthesis (DBT), breast ultrasound and CEM. EXPLORATORY OBJECTIVES: I. To compare the outcomes/endpoints stratified by age to determine if age affects the ability of CEM to accurately define a lesion as benign, probably benign or suspicious. OUTLINE: Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day or up to 3 days later.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Contrast Enhanced Digital Mammography	Undergo CEM

Timeline

• Start date: 2020-06-23
• Primary completion: 2021-12-31
• Completion: 2023-01-27
• First posted: 2019-04-29
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States