Clinical trial NCT03929783: Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings
Official title: Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 107
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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?

Primary outcomes:
measure: Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
timeFrame: Up to 1 year
measure: Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
timeFrame: Up to 1 year
measure: Sensitivity of US to classify a lesion as benign, probably benign, or suspicious
timeFrame: Up to 1 year
measure: Specificity of CEM to classify a lesion as benign, probably benign, or suspicious
timeFrame: Up to 1 year
measure: Specificity of MM to classify a lesion as benign, probably benign, or suspicious
timeFrame: Up to 1 year
measure: Specificity of US to classify a lesion as benign, probably benign, or suspicious
timeFrame: Up to 1 year
measure: False negative rate of CEM
timeFrame: Up to 1 year
measure: False negative rate of MM
timeFrame: Up to 1 year
measure: False negative rate of US
timeFrame: Up to 1 year
measure: False positive rate of CEM
timeFrame: Up to 1 year
measure: False positive rate of MM
timeFrame: Up to 1 year
measure: False positive rate of US
timeFrame: Up to 1 year
Secondary outcomes:
measure: Positive predictive value of CEM
timeFrame: Up to 1 year
measure: Positive predictive value of MM
timeFrame: Up to 1 year
measure: Positive predictive value of US
timeFrame: Up to 1 year
measure: Negative predictive value of CEM
timeFrame: Up to 1 year
measure: Negative predictive value of MM
timeFrame: Up to 1 year
measure: Negative predictive value of US
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Lydia Liao
role: PRINCIPAL_INVESTIGATOR
References: