Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Contrast Enhanced Digital Mammography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with digital breast tomosynthesis and/or ultrasound assessments of Breast Imaging Reporting and Data System (BI-RADS) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis. Abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or > 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings. Scheduled for imaging guided percutaneous needle biopsy. Provide signed and dated informed consent form. If patient is of childbearing potential, a negative pregnancy test, urine or blood, within 14 days prior to the scan. Exclusion Criteria: < 1 cm span of calcifications without an ultrasound correlate. Pregnant patients. Patients with known allergy to iodinated contrast material. If patient answers YES to any of the below questions they need glomerular filtration rate (gFR) prior to contrast administration regardless of their age: Have you ever been told you have renal problems? Have you ever been told you have protein in your urine? Do you have high blood pressure? Do you have diabetes? Do you have gout? Have you ever had kidney surgery?

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (CEM)<br>Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day. | Procedure: Contrast Enhanced Digital Mammography<br>* Undergo CEM<br>* Other names: Contrast Enhanced Spectral Mammography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious | The total number of suspicious and benign lesions on each modality (mammogram+ultrasound [MM+US] and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| Sensitivity of US to classify a lesion as benign, probably benign, or suspicious | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| Specificity of CEM to classify a lesion as benign, probably benign, or suspicious | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| Specificity of MM to classify a lesion as benign, probably benign, or suspicious | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| Specificity of US to classify a lesion as benign, probably benign, or suspicious | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| False negative rate of CEM | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| False negative rate of MM | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| False negative rate of US | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| False positive rate of CEM | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| False positive rate of MM | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 
| False positive rate of US | The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of CEM | The positive predictive value of CEM will be calculated and compared to MM+US. | Up to 1 year | 
| Positive predictive value of MM | The positive predictive value of CEM will be calculated and compared to MM+US. | Up to 1 year | 
| Positive predictive value of US | The positive predictive value of CEM will be calculated and compared to MM+US. | Up to 1 year | 
| Negative predictive value of CEM | The negative predictive value of CEM will be calculated and compared to MM+US. | Up to 1 year | 
| Negative predictive value of MM | The negative predictive value of CEM will be calculated and compared to MM+US. | Up to 1 year | 
| Negative predictive value of US | The negative predictive value of CEM will be calculated and compared to MM+US. | Up to 1 year |