Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening and Diagnosis of Breast Cancer

NCT ID: NCT05243121

Last Updated: 2022-02-16

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

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2025-09-30

Brief Summary

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Use Convolutional Neural Networks Analysis for Classification of Contrast-enhancing Lesions at Multiparametric Breast MRI. Build an abbreviated protocal, and investigate whether an abbreviated protocol was suitable for breast magnetic resonance imaging screening for breast mass in Chinese women, which can shorten the examination time and avoid enhanced imaging while ensuring the accuracy of the diagnosis.

Detailed Description

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Conditions

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Breast Neoplasms Magnetic Resonance Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinically symptomatic patients

Clinically symptomatic patients (defined as palpable masses, nipple discharge, asymmetric thickening or nodules, and abnormal skin changes according to the guidelines) should be examined by BMRI at the judgment of the clinician.

MRI

Intervention Type DIAGNOSTIC_TEST

undergoing enhanced MRI

Interventions

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MRI

undergoing enhanced MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with clinical symptoms (define as palpable mass, nipple discharge, asymmetric thickening or nodules, and abnormal skin changes)
* Patients undergoing full sequence BMRI examination
* Through the follow-up database, at least 6 months of follow-up results can be obtained to determine whether the diagnosis result is negative/benign/malignant; for patients who need pathological biopsy, the pathological biopsy results shall prevail to determine the lesion benign/malignant

Exclusion Criteria

* The breast had received radiotherapy, chemotherapy, biology and other treatments before BMRI.
* There are contraindications for breast-enhanced MRI examinations such as allergy to contrast agents.
* A prosthesis is implanted in the affected breast.
* Patients during lactation or pregnancy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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WangYi

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking university people's hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Wang, doctor

Role: CONTACT

86+010-88325813

Facility Contacts

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Yi Wang, doctor

Role: primary

13331183901

Other Identifiers

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AI-BMRI-S

Identifier Type: -

Identifier Source: org_study_id

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