Efficacy and Safety of Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Sentinel lymph node detection rate.
研究概览
简要总结
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.
详细描述
All enrolled subjects with breast cancer will receive Technetium Tc 99m Sulfur Colloid Injection and Mitoxantrone Hydrochloride Injection for Tracing sequentially, to evaluate the efficacy of the two methods for sentinel lymph node (SLN) mapping in breast cancer patients. Due to the characteristics of the investigational product and sentinel lymph node biopsy (SLNB) procedure, blinding is not feasible for this trial; therefore, an open-label design is adopted.
At least 8 subjects will be enrolled in the initial exploratory phase to investigate the lymph node uptake of 99mTc-SC, and to determine the optimal administration time, dosage, and preoperative SPECT/CT imaging schedule. These 8 subjects will not be included in the final efficacy and safety analysis set, and an additional 8 subjects will be enrolled subsequently.
- At least 4 subjects will receive no more than 0.5 mCi of Technetium Tc 99m Sulfur Colloid Injection at 6 h ± 36 min before surgery. Dynamic scintigraphy (5 min per frame, with supplementary lateral imaging of the ipsilateral side) will be performed for 60 minutes as soon as possible (2-3 min) after injection. Planar static imaging (anterior and ipsilateral lateral views) of the ipsilateral breast and axillary regions will be conducted at 2 h ± 12 min and 3 h ± 18 min, and SPECT/CT imaging (anterior view, ipsilateral lateral view, and tomographic scan) will be performed at 5 h ± 30 min, for a total of 4 scans.
- At least 4 subjects will receive no more than 1 mCi of Technetium Tc 99m Sulfur Colloid Injection at 18 h ± 120 min before surgery. Dynamic scintigraphy within 60 minutes (5 min per frame, with supplementary lateral imaging of the ipsilateral side) will be acquired as soon as possible (2-3 min) after injection. Planar static imaging (anterior and ipsilateral lateral views) of the ipsilateral breast and axillary regions will be performed at 2 h ± 12 min, 3 h ± 18 min and 6 h ± 36 min, and SPECT/CT imaging (anterior view, ipsilateral lateral view, and tomographic scan) will be conducted at 18 h ± 120 min, for a total of 5 scans.
For the remaining subjects, procedures will be implemented based on the exploratory results from the aforementioned 8 subjects:
- For subjects undergoing same-day SLNB: 0.5 mCi of 99mTc-SC will be administered; SPECT/CT imaging will be performed at 2 h ± 12 min to 5 h ± 30 min after dosing, and SLNB will be conducted at 3-6 h ± 36 min after dosing.
- For subjects undergoing next-day SLNB: 1 mCi of 99mTc-SC will be administered; SPECT/CT imaging will be performed at 3 h ± 30 min to 18 h ± 120 min after dosing, and SLNB will be completed within 18 h ± 120 min after dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to understand and voluntarily sign a written informed consent.
- •Female subjects aged 18-70 years ( including 18 and 70 years ).
- •Histologically confirmed diagnosis of invasive breast cancer or primary invasive breast cancer or ductal carcinoma in situ (DCIS) ；
- •Clinical stage 1 or 2；
- •For subjects undergoing surgical treatment, axillary sentinel lymph node biopsy is part of the surgical plan；
- •The axillary lymph nodes were negative by imaging examination or confirmed by fine needle aspiration.
- •Conventional preoperative examination showed no clear surgical contraindications
排除标准
- •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
研究组 & 干预措施
Experimental: 99mTc-SC and MHI Intra-individual Control Group
All enrolled patients will receive both Technetium [99mTc] Sulfur Colloid Injection (99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracer (MHI) as intra-individual controls prior to sentinel lymph node biopsy (SLNB). 1. 99mTc-SC Administration: Administered subcutaneously (peritumoral or subareolar) 3 to 18 hours prior to surgery. The dosage is scheduled based on surgery timing:
Same-day SLNB: 0.5 mCi 99mTc-SC injected 3 to 6 hours (±36 min) before SLNB. Next-day SLNB: 1.0 mCi 99mTc-SC injected 3 to 18 hours (±120 min) before SLNB. 2. MHI Administration: 0.5 to 2.0 mL (5.0 mg/mL) of MHI is injected subcutaneously (peritumoral or deep subcutaneous) approximately 15 minutes before SLNB, followed by local massage for 5 to 8 minutes.
Sentinel lymph nodes (SLNs) will be localized and identified intraoperatively using a handheld gamma detector probe (hot spots) and visual inspection for blue staining.
干预措施: Technetium Tc 99m Sulfur Colloid Injection (Drug)
Experimental: 99mTc-SC and MHI Intra-individual Control Group
All enrolled patients will receive both Technetium [99mTc] Sulfur Colloid Injection (99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracer (MHI) as intra-individual controls prior to sentinel lymph node biopsy (SLNB). 1. 99mTc-SC Administration: Administered subcutaneously (peritumoral or subareolar) 3 to 18 hours prior to surgery. The dosage is scheduled based on surgery timing:
Same-day SLNB: 0.5 mCi 99mTc-SC injected 3 to 6 hours (±36 min) before SLNB. Next-day SLNB: 1.0 mCi 99mTc-SC injected 3 to 18 hours (±120 min) before SLNB. 2. MHI Administration: 0.5 to 2.0 mL (5.0 mg/mL) of MHI is injected subcutaneously (peritumoral or deep subcutaneous) approximately 15 minutes before SLNB, followed by local massage for 5 to 8 minutes.
Sentinel lymph nodes (SLNs) will be localized and identified intraoperatively using a handheld gamma detector probe (hot spots) and visual inspection for blue staining.
干预措施: Mitoxantrone Hydrochloride Injection for Tracing (Drug)
结局指标
主要结局
Sentinel lymph node detection rate.
时间窗: During surgery (Day 0 or Day 1))
次要结局
- The consistency between 99mTc-SC and MHI(Intraoperatively during sentinel lymph node biopsy (Day 0 or Day 1))
- The coincidence between 99mTc-SC and MHI(Up to 14 days post-surgery (Day 14 ± 3))
- Observe the incidence and severity of adverse events ( AE ) and severe adverse events ( SAE ), as well as abnormal laboratory test indicators.(From study drug administration through 14 days post-surgery (Day 14 ± 3))