Clinical trial NCT04951245: Ultrasound-assisted CNSs Mapping Versus Dual-tracer-guided Sentinel Lymph Node Biopsy
Official title: Ultrasound-assisted Carbon Nanoparticle Suspensions Mapping Versus Dual-tracer-guided Sentinel Lymph Node Biopsy in Patients With Early Breast Cancer (UltraCars): a Prospective, Randomized Controlled Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. The participants must be female and 18 years of age or older.
2. Resectable invasive adenocarcinoma of the breast, confirmed histologically.
3. Ductal carcinoma in situ confirmed histologically.
4. The participants must be a preoperative clinical Tis, T1, T2, T3 as well as clinical M0 breast cancer.
5. Without clinical or radiological nodal involvement (cN0): No positive ipsilateral axillary lymph nodes; No prior removal of ipsilateral axillary lymph nodes; No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy.
6. With clinical positive lymph nodes (cN1) (including any abnormal or enlarged clinically palpable lymph nodes or core biopsy/surgical biopsy/FNA evidence of malignant cell within any lymph nodes) that was downstaged to cN0 following neoadjuvant therapy.
7. The participants must have an ECOG performance status of Grade 0-1.
8. The participants must provide written informed consent before participating in the study.

Exclusion criteria:

1. The breast has ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. Tethering or dimpling of the skin or nipple inversion allowed.
2. The participants has a known hypersensitivity to tracers planned for use during SLNB.
3. Other prior breast malignancy except lobular carcinoma in situ.
4. The participants has had prior breast implants.
5. The participants has had prior breast reduction surgery.
6. The participants has had other prior surgery in the upper, outer quadrant, areola, or axilla to the indicated breast.
7. The participants has a positive pregnancy test or is lactating.
8. The participants has participated in another investigational drug study during the 30 days prior to signing informed consent.

Primary outcomes:
measure: The identification rate of SLNs
timeFrame: within 14 days of SLNB
Secondary outcomes:
measure: The mean number of SLNs collected
timeFrame: within 14 days of SLNB
measure: Operative time
timeFrame: within 14 days of SLNB
measure: Intraoperative or postoperative complications
timeFrame: within 30 days of SLNB
Other outcomes:
measure: Identification rate of SLNs in post-NCT patients
timeFrame: within 14 days of SLNB
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Kun Wang, MD
role: STUDY_CHAIR
References:
citation: Zhang L, Cheng M, Lin Y, Zhang J, Shen B, Chen Y, Yang C, Yang M, Zhu T, Gao H, Ji F, Li J, Wang K. Ultrasound-assisted carbon nanoparticle suspension mapping versus dual tracer-guided sentinel lymph node biopsy in patients with early breast cancer (ultraCars): phase III randomized clinical trial. Br J Surg. 2022 Nov 22;109(12):1232-1238. doi: 10.1093/bjs/znac311.