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Feasibility of sentinel lymph node biopsy using dye alone method in Chinese patients with cN1 breast cancer after neoadjuvant chemotherapy evaluated by clinical physical examination and three-dimensional ultrasound: a prospective, multicenter, diagnostic trial

Feasibility of sentinel lymph node biopsy using dye alone method in Chinese patients with cN1 breast cancer after neoadjuvant chemotherapy evaluated by clinical physical examination and three-dimensional ultrasound: a prospective, multicenter, diagnostic trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026929
Enrollment
Unknown
Registered
2019-10-26
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-10-28

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:Gold standard is the paraffin pathological results after ALND. Reference standard is Expert Consensus and Technical Guidelines for Sentinel Lymph Node Biopsy of Early Breast Cancer with
lymph&#32
biopsy

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) women, age at 18-70 years; (2) primary invasive breast adenocarcinoma confirmed by physical examination, breast color Doppler ultrasound, mammography, MRI evaluation, and hollow needle histological examination; (3) those who have not previously received treatment for breast cancer, agree to participate in the study, and have good compliance; (4) the Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2; (5) before treatment, the results of hematological and biochemical examinations should meet the following conditions: white blood cells >= 4.0 x 10^9/L, absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 90 g/L, glutathione transaminase, alanine transaminase <= 1.5 x upper limit of normal, creatinine <= 1.5 x upper limit of normal, total bilirubin <= 1.5 x upper limit of normal; (6) provision of written informed consent.

Exclusion criteria

Exclusion criteria: (1) serious heart, liver or kidney diseases; (2) lactating or pregnant women; (3) patients with confirmed distant metastasis of breast cancer; (4) patients with sensory or motor neuropathy, or those diagnosed with psychiatric disorder; (5) patients with confirmed cardiovascular diseases, serious concomitant diseases or active infections including known human immunodeficiency virus infection; (6) patients with history of other cancers; (7) patients allergic to drugs and excipients involved in tracers and neoadjuvant chemotherapy.

Design outcomes

Primary

MeasureTime frame
False negative rate of sentinel lymph node biopsy;

Secondary

MeasureTime frame
Relationship between each influential factor and the results of sentinel lymph node biopsy after neoadjuvant chemotherapy;Adverse events;

Countries

China

Contacts

Public ContactBo Chen

The First Affiliated Hospital of China Medical University

chbyxl@163.com+86 15904025211

Outcome results

None listed

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