A Phase 3 interventional study of UC group: ultrasound-assisted CNSs guided and GC group: CNSs plus ICG dual-tracer-guided in Breast Cancer, sponsored by Guangdong Provincial People's Hospital. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by Guangdong Provincial People's Hospital · Phase 3, Interventional, and Treatment
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.
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.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 330 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
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Exclusion criteria:
Ultrasound-assisted CNSs guided SLN mapping
Procedure: UC group: ultrasound-assisted CNSs guided
CNSs plus ICG dual-tracer-guided SLN mapping
Procedure: GC group: CNSs plus ICG dual-tracer-guided
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.
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.
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.
Time frame: within 14 days of SLNB
The mean number of SLNs collected
Defined as the number of tracer-stained or palpable SLNs divided by the number of patients whose SLNs were identified.
Time frame: within 14 days of SLNB
Operative time
Defined as the time from skin incision to resection of the SLNs specimens in patients whose at least one SLN were detected.
Time frame: within 14 days of SLNB
Intraoperative or postoperative complications
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.
Time frame: within 30 days of SLNB
Identification rate of SLNs in post-NCT patients
Defined as the number of patients who at least one SLN were detected divided by the total number of patients included in NCT subgroup.
Time frame: within 14 days of SLNB
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial People's Hospital