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临床试验/NCT06104085
NCT06104085招募中不适用

99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
semi-quantitative analysis

研究概览

简要总结

Human trophoblast cell-surface glycoprotein antigen 2 (Trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. Studies have shown that Trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer, etc.) and is related to the proliferation, invasion, and metastasis of tumor cells. and other processes related. According to statistics, more than 80% of breast cancer patients highly express Trop2, and high expression of Trop2 is positively correlated with shortened survival and poor prognosis of cancer patients. In this study, a single-domain antibody targeting Trop2 was selected to prepare a new nuclear medicine molecular probe 99mTc-MY6349, so as to monitor the expression level of Trop2 in patients' systemic tumors through SPECT/CT imaging. Breast cancer patients who intend to use gosatuzumab for subsequent treatment can first undergo 99mTc-MY6349 SPECT/CT imaging to detect Trop2 expression levels in systemic tumors. Subsequently, 18F-FDG PET/CT imaging was performed to compare and detect the distribution of primary tumors and systemic metastases in patients with breast cancer. This study analyzes the heterogeneity of Trop2 expression levels within the primary tumor and the heterogeneity of expression levels in systemic metastases, thereby providing a basis for testing whether the patient is suitable for subsequent treatment and conducive to the formulation of subsequent treatment plans.

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 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, aged between 18 and 80 years old.
  • Patients with suspected or definite diagnosis of triple-negative breast cancer.
  • Patients with suspected or confirmed triple-negative recurrent or metastatic breast cancer.
  • Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if they still have the ability to conceive, isolation contraceptive measures must be taken during this study period.

排除标准

  • Suffering from severe gastrointestinal, cardiovascular, liver, kidney, blood system, endocrine, respiratory system, immune deficiency and other serious diseases.
  • Claustrophobia.
  • In the past year, due to other clinical medical treatment or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50mSv.
  • Pregnant or lactating women.
  • Received experimental drug or device treatment (with unclear efficacy or safety) within 1 month.
  • There is any situation in which the conductor of this study believes that any aspect related to this experiment may cause harm or be potentially harmful.

结局指标

主要结局

semi-quantitative analysis

时间窗: through study completion, an average of 1 year

use the region of interest (ROI) method to measure the ratio of uptake at the lesion site to liver uptake

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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