Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Standardized uptake value（SUV）
研究概览
简要总结
The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);
- •Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;
- •Patients with confirmed or suspected breast cancer;
- •Expected survival ≥12 weeks;
- •Good follow-up compliance;
- •Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;
- •Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.
排除标准
- •Severe abnormal liver and kidney function;
- •Pregnant, pregnant and lactating women;
- •Can not lie flat for half an hour;
- •Unable to obtain informed consent;
- •Suffering from claustrophobia or other mental illness;
- •People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;
- •Other conditions deemed unsuitable for participation in the trial by the investigator.
研究组 & 干预措施
Diagnostic Validation Cohort
Patients with newly diagnosed or suspected breast cancer will undergo one [68Ga]Ga-TTP scan and one [18F]FDG scan within 1 week, in randomized order, with no anticancer treatment administered between the two imaging examinations. This cohort is used to evaluate tumor targeting, compare diagnostic performance with [18F]FDG, and correlate imaging findings with pathology and TROP2 expression.
干预措施: 18F-FDG (Drug)
ADC Response Assessment Cohort
Patients with breast cancer who are planned to receive TROP2-directed ADC therapy will undergo paired [68Ga]Ga-TTP and [18F]FDG imaging at three time points: before treatment, after 2 cycles of ADC therapy(each cycle is 21 days), and at disease progression. This cohort is used to assess longitudinal imaging changes and their relationship with treatment response.
干预措施: [68Ga]Ga-TTP (Drug)
ADC Response Assessment Cohort
Patients with breast cancer who are planned to receive TROP2-directed ADC therapy will undergo paired [68Ga]Ga-TTP and [18F]FDG imaging at three time points: before treatment, after 2 cycles of ADC therapy(each cycle is 21 days), and at disease progression. This cohort is used to assess longitudinal imaging changes and their relationship with treatment response.
干预措施: 18F-FDG (Drug)
Diagnostic Validation Cohort
Patients with newly diagnosed or suspected breast cancer will undergo one [68Ga]Ga-TTP scan and one [18F]FDG scan within 1 week, in randomized order, with no anticancer treatment administered between the two imaging examinations. This cohort is used to evaluate tumor targeting, compare diagnostic performance with [18F]FDG, and correlate imaging findings with pathology and TROP2 expression.
干预措施: [68Ga]Ga-TTP (Drug)
结局指标
主要结局
Standardized uptake value（SUV）
时间窗: 2 years
The uptake of the tracer （68Ga-TTP） in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.
次要结局
未报告次要终点
研究者
Hua Zhu
Associate Professor
Peking University Cancer Hospital & Institute