Diagnostic Performance of Contrast-Enhanced Mammography

ConditionMammography
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-80
SponsorZHOU Yidong

About this trial

Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. The advantages of CEM are dramatically apparent in women with dense breasts. The purpose of this study was to investigate the additional diagnostic value of CEM added to the standard practice of mammography plus ultrasonography(US) in patients with suspicious breast lesions.

This study was a single-center prospective-retrospective combined observational study. In the prospective part, women with suspected breast abnormalities undergo prospective CEM evaluation, including acquisition of low energy (LE) images and recombined images (RI) showing enhancement, concurrently with breast US. The retrospective part selected the mammography and breast US data of female patients with suspected breast abnormalities who had previous baseline matching.

Eligibility criteria

Qualifiers

Breast ultrasound or/and general mammography suggest that the lesion is BI-RADS 4 or above;

Willing to undergo enhanced mammography examination;

Agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary.

Disqualifiers

Allergy to iodinated contrast;

Pregnant and lactating women;

Suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis;

The breast is too large to be completely included in the full-field mammography examination at one time; ○5 Those with breast implants.

Trial design

Treatments tested in this trial

  • Contrast-Enhanced Mammography

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators

ZHOU Yidong

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution