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Precise Screening for Asymptomatic Female Breast Cancer in Southern Sichuan Region: Diagnostic Value of Combined Ultrasound and Enhanced MRI Protocol and Localization Validation of BCSC/Gail/PUMCH Models

Systematized Research and Application Demonstration of Appropriate Technologies for Major Chronic Disease Prevention and Control: Precise Screening for Asymptomatic Female Breast Cancer in Southern Sichuan Region: Diagnostic Value of Combined Ultrasound and Enhanced MRI Protocol and Localization Validation of BCSC/Gail/PUMCH Models - Diagnostic Value of Combined Ultrasound and Enhanced MRI Protocol and Localization Validation of BCSC/Gail/PUMCH Models

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122895
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Gold Standard:The histopathological diagnosis of breast lesion specimens obtained through ultrasound/MRI-guided biopsy or surgical resection serves as the gold standard for breast cancer diagnosis
for breast cancers diagnosed during the 1-year follow-up period, the final pathological diagnosis result is used as the reference standard.
Index test:Breast ultrasound combined with breast enhanced magnetic resonance imaging (BMRI) examination

Sponsors

Zigong First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 35 - 65 years old; 2. No symptoms related to breast cancer; 3. Voluntary to sign the informed consent form and cooperate with 1-year follow-up; 4. No contraindications for MRI examination (no metal implants, no allergy to contrast agents, normal renal function).

Exclusion criteria

Exclusion criteria: 1. Previous history of breast cancer / breast carcinoma in situ or history of breast surgery; 2. Those with breast implantation; 3. Pregnant women / lactating women, women in the premenstrual period, those with severe liver or kidney dysfunction, those with coagulation disorders, and those who refuse pathological biopsy or follow-up.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of breast ultrasound combined with enhanced MRI for breast cancer screening;

Secondary

MeasureTime frame
Incidence of interval breast cancer during 1-year follow-up;Predictive performance of BCSC, Gail and PUMCH breast cancer risk prediction models;The incidence rate of adverse events related to breast enhanced MRI examinations;

Countries

China

Contacts

Public ContactZhao Qian

Zigong First People's Hospital

781380511@qq.com+86 139 9002 3506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026