Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

NCT03929783 | Completed

• 2 other identifiers: 19D.203JT 13786
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• Positive predictive value of CEM

  Up to 1 year

• Positive predictive value of MM

  Up to 1 year

• Positive predictive value of US

  Up to 1 year

• Negative predictive value of CEM

  Up to 1 year

• Negative predictive value of MM

  Up to 1 year

Study Arms (1)

Diagnostic (CEM)

EXPERIMENTAL

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

Interventions

Contrast Enhanced Digital Mammography PROCEDURE

Undergo CEM

Also known as: CEDM, Contrast Enhanced Spectral Mammography

Diagnostic (CEM)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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?

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lydia Liao

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: June 23, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 27, 2023
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)