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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

This trial does not accept healthy volunteers

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 population

Patients with breast lesions BI-RADS 4 and above treated at the Breast Surgery Department of Peking Union Medical College Hospital.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Contrast-Enhanced Mammography

    Diagnostic test

    Only patients in the prospective cohort will undergo CEM in addition to breast ultrasound.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: prospective cohort1 intervention
Group B: retrospective cohort0 interventions

Trial outcomes

Primary outcomes

1

lesion biopsy rate

Total biopsy rate (including core needle biopsy and lesion excision biopsy) in patients with BI-RADS 4 and above with and without CEM.

Time frame
2 years
2

breast cancer detection rate

Proportion of breast cancer detected among all patients undergoing biopsy.

Time frame
2 years

Secondary outcomes

1

number of BI-RADS score upgrade

number of BI-RADS score upgrade during follow-up

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ZHOU Yidong

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: