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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03929783

Enrollment

107

Registered

2019-04-29

Start date

2020-06-23

Completion date

2023-01-27

Last updated

2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

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.

Interventions

PROCEDUREContrast Enhanced Digital Mammography

Undergo CEM

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 80 Years

Healthy volunteers

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?

Design outcomes

Primary

Measure	Time frame	Description
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.
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 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 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.
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 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 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.
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 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.
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.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026