Breast Cancer Clinical Trial
— UltraCarsOfficial 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
Verified date | January 2022 |
Source | Guangdong Provincial People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 330 |
Est. completion date | June 1, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong General Hospital | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | within 14 days of SLNB | |
Primary | 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 | 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. | within 14 days of SLNB | |
Secondary | Operative time | Defined as the time from skin incision to resection of the SLNs specimens in patients whose at least one SLN were detected. | within 14 days of SLNB | |
Secondary | 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. | within 30 days of SLNB |
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