Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women

NCT04996615 | Unknown

• 1 other identifier: AI-BMRI
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief Summary

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 cancer in high-risk Chinese women, which can shorten the examination time and avoid enhanced imaging while ensuring the accuracy of the diagnosis.

Conditions

Breast Cancer; Magnetic Resonance Imaging

Keywords

breast cancer; screening; high risk women; magnetic resonance imaging; deep learning

Outcome Measures

Primary Outcomes (1)

• screening yield

  compare the rates of detection of breast cancers in the screening of high-risk populations between the Breast MRI full sequence, contrast-enhanced and non-contrast-enhanced sequence.

  5 years

Secondary Outcomes (1)

• The accuracy of radiologists and deep learning models

  5 years

Study Arms (1)

high risk population

women at high risk of breast cancer undergoing enhanced MRI

Other: no intervention

Interventions

no intervention OTHER

no intervention

high risk population

Eligibility Criteria

• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

23

You may qualify if:

• Patients undergoing full sequence BMRI examination
• Written informed consent and complete the clinical data questionnaire
• 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.

You may not qualify if:

• The breast had received radiotherapy, chemotherapy, biology and other treatments before BMRI.
• Signs or symptoms of breast disease
• There are contraindications for breast-enhanced MRI examinations such as allergy to contrast agents.
• Patients during lactation or pregnancy

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (2)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

shu wang, doctor

CONTACT

86+010-88324010; shuwang@pkuph.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Breast Center

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 9, 2021
• Study Start: September 1, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)