Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Neoplasms
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 30 years and 80 years
- Gender
- Only males
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 class...
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.
Tracking Information
- NCT #
- NCT03929783
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lydia Liao Sidney Kimmel Cancer Center at Thomas Jefferson University