Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    100
  • sponsor
    Thomas Jefferson University
Updated on 1 March 2021

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.

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.

Details
Condition Breast Cancer, breast tumors, tumor of the breast, breast tumor
Treatment Contrast Enhanced Digital Mammography
Clinical Study IdentifierNCT03929783
SponsorThomas Jefferson University
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

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?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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