Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929783
• Other study ID #: 19D.203
• Status: Completed
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: January 27, 2023

Study information

• Verified date: February 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 27, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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?

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• Contrast Enhanced Digital Mammography
Undergo CEM

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Positive predictive value of CEM	The positive predictive value of CEM will be calculated and compared to MM+US.	Up to 1 year
Secondary	Positive predictive value of MM	The positive predictive value of CEM will be calculated and compared to MM+US.	Up to 1 year
Secondary	Positive predictive value of US	The positive predictive value of CEM will be calculated and compared to MM+US.	Up to 1 year
Secondary	Negative predictive value of CEM	The negative predictive value of CEM will be calculated and compared to MM+US.	Up to 1 year
Secondary	Negative predictive value of MM	The negative predictive value of CEM will be calculated and compared to MM+US.	Up to 1 year
Secondary	Negative predictive value of US	The negative predictive value of CEM will be calculated and compared to MM+US.	Up to 1 year