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COMPLETED

NCT07764653

PHASE3

Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer

Sponsor: HTA Co., Ltd.

View on ClinicalTrials.gov

Summary

The aim of the study is a prospective multicentre phase-3 study that aims to evaluate the detection rate of sentinel lymph node in patients with breast cancer. To compare the detection rates of Technetium Tc 99m Sulfur Colloid Injection(99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracing(MHI) for lymphatic tracing in patients with breast cancer.

Official title: Efficacy and Safety of Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

213

Start Date

2024-01-02

Completion Date

2025-06-03

Last Updated

2026-08-14

Healthy Volunteers

Conditions

Sentinel Nodes Breast Cancer

Interventions

DRUG

Technetium Tc 99m Sulfur Colloid Injection

Technetium \[99mTc\] Sulfur Colloid Injection (0.1-1.0 mCi; specifically 0.5 mCi for same-day surgery administered 3-6 hours prior to SLNB, or 1.0 mCi for next-day surgery administered 3-18 hours prior to SLNB) is administered via subcutaneous injection over the tumor surface (or subareolar region in cases with biopsy cavities or upper-outer quadrant tumors near the axilla). Preoperative SPECT/CT imaging is performed. Intraoperatively, a handheld gamma detector probe (GDP) is used to identify and locate "hot spot" sentinel lymph nodes (SLNs).

DRUG

Mitoxantrone Hydrochloride Injection for Tracing

Mitoxantrone Hydrochloride Injection for Tracing (0.5-2.0 mL, 5.0 mg/mL) is administered approximately 15 minutes prior to surgery via subcutaneous injection around the tumor or behind the areola for total mastectomy, or deep peritumoral subcutaneous injection for breast-conserving surgery, followed by local massage for 5-8 minutes. Intraoperatively, blue-stained lymph nodes and/or blue lymphatic channels pointing to lymph nodes are visually identified as SLNs

Inclusion criteria 1. Able to understand and voluntarily sign a written informed consent. 2. Female subjects aged 18-70 years ( including 18 and 70 years ). 3. Histologically confirmed diagnosis of invasive breast cancer or primary invasive breast cancer or ductal carcinoma in situ (DCIS) ； 4. Clinical stage 1 or 2； 5. For subjects undergoing surgical treatment, axillary sentinel lymph node biopsy is part of the surgical plan； 6. The axillary lymph nodes were negative by imaging examination or confirmed by fine needle aspiration. 7. Conventional preoperative examination showed no clear surgical contraindications Exclusion criteria 1)Participants are allergic to the test drug or its excipients or have a history of severe drug allergy ; 2)Participants with prior surgery for breast cancer or neoadjuvant chemotherapy ; 3)inflammatory breast cancer ; 4)Ipsilateral axillary clinical examination or imaging examination positive or puncture lymph node pathology positive, no breast cancer histopathological diagnosis or no puncture pathological examination ; 5)Have received any form of breast augmentation surgery ; 6)Participants with liver or kidney dysfunction, ALT, AST\>2.5 times ULN, Bilirubin \>1.5 times ULN, Serum creatinine \>1.5 times, or Investigators believe that liver and / or kidney damage to the extent that patients should not participate in this study;； 7)With serious or uncontrollable diseases : such as severe cardiovascular and cerebrovascular diseases ( blood disease, chronic congestive heart failure NYHA classification ≥ III level, etc. ), severe pulmonary insufficiency ( one second rate FEV1 / FVC \< 50 % or FEV1 \< 50 % predicted value or maximum ventilation volume per minute MVV \< 50L / min ), psychiatric patients ; 8)Participants with active infection of infectious diseases screening ( hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody ) ; 9)participated in clinical trials of other drugs within 3 months before screening; 10)) Patients with positive pregnancy test or pregnancy plan during lactation or screening period to 3 months after administration and unwilling to take effective contraceptive measures or egg donation plan; 11)Investigators considered that it was not suitable for the patients to participate in this trial

Locations (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China