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The application of superparamagnetic iron oxide (SPIO) contrast agents to trace lymphatic drainage areas for sentinel lymph node biopsy of breast cancer

The application of superparamagnetic iron oxide (SPIO) contrast agents to trace lymphatic drainage areas for sentinel lymph node biopsy of breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077785
Enrollment
Unknown
Registered
2023-11-20
Start date
2023-11-20
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

breast cancer

Interventions

study group:Before operation, the patients were given methylene blue dye and RESOVIST injection combined with magnetic detector in vitro for signal collection.
study group:After neoadjuvant therapy, the patients in a lower stage were given methylene blue dye and RESOVIST injection combined with magnetic detector in vitro for signal collection.

Sponsors

the First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)adult women aged 18-75 years,patients with axillary node-negative early breast cancer planned for Sentinel lymph node biopsy; (2)adult women aged 18-75 years,patients with locally advanced breast cancer who completed a full course of neoadjuvant therapy had negative axillary downgrade and planned for Sentinel lymph node biopsy.

Exclusion criteria

Exclusion criteria: (1) intolerance or hypersensitivity to iron or glucose, (2) pregnancy or lactation, (3) pacemaker or other iron-containing device on chest wall; (4) liver failure or renal failure (creatinine =1.1, AST =50, ALT =40, T-bil =1.5).

Design outcomes

Primary

MeasureTime frame
Detection rate per case;

Secondary

MeasureTime frame
Lymph node detection rate;Malignant tumor rate;

Countries

China

Contacts

Public ContactLina Zhang

the First Affiliated Hospital of China Medical University

zhanglnda@163.com+86 138 9812 2867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026