Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

NCT ID: NCT03929783

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2023-01-27

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (CEM)

Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day.

Group Type: EXPERIMENTAL

Contrast Enhanced Digital Mammography

Intervention Type: PROCEDURE

Undergo CEM

Interventions

Contrast Enhanced Digital Mammography

Undergo CEM

Intervention Type: PROCEDURE

Other Intervention Names

CEDM; Contrast Enhanced Spectral Mammography

Eligibility Criteria

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?

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lydia Liao

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 13786

Identifier Type: OTHER

Identifier Source: secondary_id

19D.203

Identifier Type: -

Identifier Source: org_study_id