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临床试验/NCT05976620
NCT05976620已完成不适用

Clinical Study of 18F Labeled Probe Targeting Fibroblast Activation Protein Inhibitor and Integrin avβ3 (FAPI-RGD) in Breast Tumors

Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Correlation between clinical indicators and PET/CT results

研究概览

简要总结

The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

详细描述

Breast cancer is the most common malignant disease in women worldwide.Early detection, accurate diagnosis and staging are the keys to effective treatment for breast cancer patients.18F-FDG PET/CT has become an important imaging method for the diagnosis and staging of breast cancer.However,FDG PET has certain limitations, including false-positive uptake for acute and chronic infections and false-negative uptake for less aggressive histological subtypes of breast cancer.In a number of studies, 68Ga-FAPI PET was positively correlated with the pathological grade and end-stage of primary breast cancer lesions, and SUVmax could predict tumor grade, final stage and lymph node metastasis. Compared with 18F-FDG,68Ga-FAPI PET/CT had higher specificity and accuracy in judging lymph node metastasis.Integrin αvβ3 is highly expressed in neovascular endothelial cells and tumor cells including breast cancer, and plays an important role in regulating tumor growth, angiogenesis, local invasion and metastasis potential.The use of integrin αvβ3 specific imaging probes derived from RGD peptides in breast cancer patients has also been reported.

Several studies have confirmed that the heterodimer is superior to the corresponding monomer due to the polyvalent effect, thus improving the binding affinity and increasing the number of effective receptors.In order to simultaneously target FAP and integrin αvβ3, we synthesized the heterodimeric peptide FAPI-RGD from FAPI and RGD.FAPI-RGD is a heterodimeric peptide that targets FAP and αvβ3-integrin receptors. 68Ga-FAPI-RGDPET/CT imaging has been used in clinical imaging studies in patients with a variety of tumors.Therefore, we plan to use 18F-FAPI-RGD PET/CT imaging for the diagnosis and treatment of breast cancer, and preliminary experiments have confirmed that this examination has a good imaging effect.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and above
  • No gender difference
  • Patients who have been diagnosed with, or are clinically highly suspected of, breast tumors and have had no other treatment within 3 months
  • Tumor size (T), lymph node status (N), and overall clinical stage of diagnosed patients were determined according to the American Joint Committee on Cancer criteria revised in 2010

排除标准

  • Patients with a second primary tumor
  • Pregnant or breastfeeding
  • Severe liver or kidney disease
  • Claustrophobia or other PET/CT scan contraindications

结局指标

主要结局

Correlation between clinical indicators and PET/CT results

时间窗: 2 months

Correlation of Immunohistochemical indexes, ultrasound, X-ray, CT, MRI, tumor markers,estrogen assay and 18F-FAPI-RGD PET/CT results

次要结局

未报告次要终点

研究者

发起方
Sichuan Provincial People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Wang

Principal Investigator

Sichuan Provincial People's Hospital

研究点 (1)

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