Ultrasound-assisted CNSs Mapping Versus Dual-tracer-guided Sentinel Lymph Node Biopsy

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04951245
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

The investigators suggested ultrasound-assisted Carbon nanoparticle suspensions (CNSs) mapping had great clinical value in clinical application and might serve as a useful alternative to the dual-tracer-guided SLNB. The investigators designed this prospective, randomized controlled phase 3 trial, to compare the feasibility and diagnostic performance of ultrasound-assisted carbon nanoparticle suspensions mapping versus dual-tracer-guided sentinel lymph node biopsy in patients with early breast cancer.

Detailed Description

The study was a single-center, open-label, randomized controlled, non-inferiority, phase 3 trial. Eligible participants were 18 year's of age or older and had histologically confirmed primary invasive breast cancer, or ductal carcinoma in situ scheduled for mastectomy, without clinical or radiological nodal involvement (cN0) or with clinical positive lymph nodes (cN1) that were downstaged to cN0 following neoadjuvant chemotherapy (NCT); and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Participants were randomly assigned (1:1) using a permuted block randomization scheme to receive either ultrasound-assisted CNSs (UC group) or CNSs plus ICG dual-tracer-guided (GC group) SLN mapping.

Study Timeline

• Study First Submitted: 2019-09-21
• Study Start: 2019-12-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-06-01
• Study First Submitted QC: 2021-06-26
• Study First Posted: 2021-07-06
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The identification rate of SLNs	within 14 days of SLNB	Defined as the number of patients who at least one SLN were detected divided by the total number of patients included.

Secondary Outcome Measures

Name	Time	Method
The mean number of SLNs collected	within 14 days of SLNB	Defined as the number of tracer-stained or palpable SLNs divided by the number of patients whose SLNs were identified.
Operative time	within 14 days of SLNB	Defined as the time from skin incision to resection of the SLNs specimens in patients whose at least one SLN were detected.
Intraoperative or postoperative complications	within 30 days of SLNB	An adverse event is any untoward, undesired, and/or unplanned clinical event in the form of signs, symptoms, disease, or laboratory testing, or physiological observations occurring in a human participating in a clinical study with a study drug, regardless of causal relationship.

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, China