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

NCT04951245 | Completed Phase 3 DMC

• 1 other identifier: 20190511
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The identification rate of SLNs

  Defined as the number of patients who at least one SLN were detected divided by the total number of patients included.

  within 14 days of SLNB

Secondary Outcomes (3)

• The mean number of SLNs collected

  within 14 days of SLNB

• Operative time

  within 14 days of SLNB

• Intraoperative or postoperative complications

  within 30 days of SLNB

Other Outcomes (1)

• Identification rate of SLNs in post-NCT patients

  within 14 days of SLNB

Study Arms (2)

UC group

EXPERIMENTAL

Ultrasound-assisted CNSs guided SLN mapping

Procedure: UC group: ultrasound-assisted CNSs guided

GC group

ACTIVE COMPARATOR

CNSs plus ICG dual-tracer-guided SLN mapping

Procedure: GC group: CNSs plus ICG dual-tracer-guided

Interventions

UC group: ultrasound-assisted CNSs guided PROCEDURE

1ml of CNSs was subcutaneously injected into the areolar area in the upper outer quadrant of the breast. The injection site was massaged for 15 minutes to promote drainage of the tracer to the axilla. During the intraoperative ultrasound-assisted procedure, an ultrasound diagnostic system was used. Before the incision, ultrasound-guided exploration of SLNs was performed by placing the probe on the lateral border of the breast and sliding cranially along the lateral border of the pectoralis major muscle . A sterile skin marker was then used to mark the optimal site of incision over the targeted lymph nodes, and the distance from the skin to the nodes was measured by ultrasound and recorded in millimeters. Blunt dissection was carried out to identify the CNSs-stained nodes around the marked region. Ultrasonography probe was placed repeatedly in or around the wound at different angles for adequate visualization if SLNs could not be localized with further dissection.

UC group

GC group: CNSs plus ICG dual-tracer-guided PROCEDURE

The preparation of CNSs mapping was identical to that of the UC group. 1ml of diluted ICG was subsequently injected into the areolar area in the upper outer quadrant of the breast. A NIR camera was used to visualize the subcutaneous lymph vessels and localized the SLNs. All fluorescent or black-stained lymph nodes along with any palpable suspicious nodes were removed. The remaining surgical field was reexamined to ensure complete resection of fluorescent lymph nodes.

GC group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants must be female and 18 years of age or older.
• Resectable invasive adenocarcinoma of the breast, confirmed histologically.
• Ductal carcinoma in situ confirmed histologically.
• The participants must be a preoperative clinical Tis, T1, T2, T3 as well as clinical M0 breast cancer.
• 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.
• 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.
• The participants must have an ECOG performance status of Grade 0-1.
• The participants must provide written informed consent before participating in the study.

You may not qualify if:

• 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.
• The participants has a known hypersensitivity to tracers planned for use during SLNB.
• Other prior breast malignancy except lobular carcinoma in situ.
• The participants has had prior breast implants.
• The participants has had prior breast reduction surgery.
• The participants has had other prior surgery in the upper, outer quadrant, areola, or axilla to the indicated breast.
• The participants has a positive pregnancy test or is lactating.
• The participants has participated in another investigational drug study during the 30 days prior to signing informed consent.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, China

Location

Related Publications (1)

• 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.

  PMID: 36074703 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kun Wang, MD

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: July 6, 2021
• Study Start: December 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: June 1, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

CN (1)