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NCT Number: NCT06713915

Diagnostic Performance of Contrast-Enhanced Mammography

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.

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Key information

Conditions

Mammography Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Contrast-Enhanced Mammography

Diagnostic Test

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

Primary outcomes

  1. lesion biopsy rate

    Time frame: 2 years

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

  2. breast cancer detection rate

    Time frame: 2 years

    Proportion of breast cancer detected among all patients undergoing biopsy.

Secondary outcomes

  1. number of BI-RADS score upgrade

    Time frame: 3 years

    number of BI-RADS score upgrade during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Yidong Zhou, Master

CONTACT

[email protected]

+86-10-69158720

Sponsors and collaborators

Lead sponsor

ZHOU Yidong

Other

Registry information

Official study title

Diagnostic Performance of Contrast-Enhanced Mammography in Suspicious Breast Lesions

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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