Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings
- Conditions
- Breast Neoplasms
- Interventions
- Procedure: Contrast Enhanced Digital Mammography
- Registration Number
- NCT03929783
- Lead Sponsor
- Thomas Jefferson University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 107
- 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.
-
< 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?
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (CEM) Contrast Enhanced Digital Mammography Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day.
- Primary Outcome Measures
Name Time Method Specificity of US to classify a lesion as benign, probably benign, or suspicious Up to 1 year 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.
False negative rate of US Up to 1 year 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.
Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious Up to 1 year 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.
Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious Up to 1 year 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.
Specificity of MM to classify a lesion as benign, probably benign, or suspicious Up to 1 year 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.
False negative rate of CEM Up to 1 year 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.
False negative rate of MM Up to 1 year 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.
False positive rate of MM Up to 1 year 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.
Sensitivity of US to classify a lesion as benign, probably benign, or suspicious Up to 1 year 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.
Specificity of CEM to classify a lesion as benign, probably benign, or suspicious Up to 1 year 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.
False positive rate of CEM Up to 1 year 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.
False positive rate of US Up to 1 year 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.
- Secondary Outcome Measures
Name Time Method Negative predictive value of MM Up to 1 year The negative predictive value of CEM will be calculated and compared to MM+US.
Negative predictive value of US Up to 1 year The negative predictive value of CEM will be calculated and compared to MM+US.
Positive predictive value of CEM Up to 1 year The positive predictive value of CEM will be calculated and compared to MM+US.
Positive predictive value of US Up to 1 year The positive predictive value of CEM will be calculated and compared to MM+US.
Positive predictive value of MM Up to 1 year The positive predictive value of CEM will be calculated and compared to MM+US.
Negative predictive value of CEM Up to 1 year The negative predictive value of CEM will be calculated and compared to MM+US.
Trial Locations
- Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States