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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Procedure: Contrast Enhanced Digital Mammography

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diagnostic (CEM); 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; Undergo CEM; Other Names: Contrast Enhanced Spectral Mammography; CEDM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Lydia Liao, Sidney Kimmel Cancer Center at Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2020
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): January 27, 2023

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (ACTUAL): April 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 19D.203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No