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Diagnostic Performance of Contrast-Enhanced Mammography

NCT ID: NCT06713915

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mammography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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prospective cohort

Women with suspected breast abnormalities in prospective cohort will be prospectively evaluated with CEM, including acquisition of low-energy (LE) images and reconstructed images (RI) showing enhancement, concurrently with breast ultrasound (US) evaluation.

Contrast-Enhanced Mammography

Intervention Type DIAGNOSTIC_TEST

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

retrospective cohort

The retrospective cohort will select the mammography and breast US data (BI-RADS score) of female patients with suspected breast abnormalities who had previous baseline matching.

No interventions assigned to this group

Interventions

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Contrast-Enhanced Mammography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ZHOU Yidong

OTHER

Sponsor Role lead

Responsible Party

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ZHOU Yidong

Breast Surgery Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yanna Zhang, M.D

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Department of Breast Surgery,Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Yidong Zhou, Master

Role: CONTACT

[email protected]
+86-10-69158720

Facility Contacts

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Yidong Zhou, Master

Role: primary

[email protected]
+86-10-69158720

Yanna Zhang, Doctor

Role: backup

[email protected]
+86-10-69158703

Other Identifiers

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PUMCH-breast-CEM

Identifier Type: -

Identifier Source: org_study_id