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Diagnostic Performance of Contrast-Enhanced Mammography

NCT06713915 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-12-03

No results posted yet for this study

Summary

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.

Conditions

  • Mammography

Interventions

DIAGNOSTIC_TEST

Contrast-Enhanced Mammography

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

Sponsors & Collaborators

  • ZHOU Yidong

    lead OTHER

Principal Investigators

  • Yanna Zhang, M.D · Peking Union Medical College Hospital

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06713915 on ClinicalTrials.gov