NCT06725940招募中不适用
Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET/CT With Granzyme B Imaging Probe
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR
研究概览
简要总结
To explore the efficacy of 68Ga-GZMB PET/CT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 16-65
- •histologically confirmed unilateral primary invasive breast cancer
- •Tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy
- •complete clinical and histo-pathological information
- •ECOG 0-1 within 10 days from the beginning of the study
- •Normal Bone Marrow Reserve: White blood cell count ≥ 3.0×10^9/L, Neutrophil count ≥ 1.5×10^9/L, Hemoglobin level ≥ 90g/L; Platelet count (PLT) ≥ 80×10^9/L; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, Total bilirubin ≤ 1.5 times the upper limit of normal, Serum creatinine ≤ 1.5 times the upper limit of normal, and Creatinine clearance rate > 50ml/min.
- •The patient has good compliance with the planned treatment, understands the research procedures, and has signed a written informed consent form
排除标准
- •bilateral or metastatic (stage IV) breast cancer
- •There has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
- •Severe systemic infection or other uncontrolled diseases
- •Patients with psychiatric disorders or those unable to comply with treatment due to other reasons
- •Known allergy or intolerance to the drug or its excipients
- •Having received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason in the past
- •Patients who are pregnant or lactating, as well as patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this trial.
- •Patients deemed unsuitable for participation in this study by the investigator.
结局指标
主要结局
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR
时间窗: through study completion, an average of 1 year
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer
次要结局
- Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR(through study completion, an average of 1 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT(through study completion, an average of 1 year)
- Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes(through study completion, an average of 1 year)
研究者
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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