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临床试验/NCT05170555
NCT05170555Unknown不适用

Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Diagnostic value

研究概览

简要总结

Renal Cell Carcinoma (RCC) is the second most common tumor in urology. Considering its origination from kidney, an organ with intense physiological uptake and excretion of 68Ga-PSMA, this study aims to evaluate the uptake of 68Ga-PSMA in RCC compared to 18F-FDG in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced RCC.

详细描述

Renal Cell Carcinoma (RCC) is the second most common tumor in urology. As one of the popular urinary tumors, the incidence rate increases by 2-4% per year. Localized RCC is generally cured by surgery, which has achieved good efficacy. However, advanced RCC are still the main factors influencing the survival of RCC patients due to its intrinsic resistance to conventional chemotherapy or radiotherapy. 18F-FDG PET/CT is considered to be a viable tool to assess RCC at initial presentation. However, FDG uptake in RCC is lower than most other solid tumors and is indistinguishable from benign lesions. So, it is necessary to find another effective way to detect RCC and its metastases. As in known, pro-angiogenic factors (VEGF, PDGF) are strongly upregulated in clear cell RCC, leading to high vascularized tumors. 68Ga-PSMA has been developed as a targeting imaging agent widely used in prostate cancer in prostate cancer. Thus, this prospective study is going to investigate whether 68Ga-PSMA PET/CT may be superior for diagnosis, therapy response assessment and follow-up of RCC than 18F-FDG PET/CT. Furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of prostate cancer lesions that showed high PSMA uptake on 68Ga-PSMA PET/CT, we'll try to assess the safety and therapeutic response to 177Lu-EB-PSMA-617 in patients with RCC.

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
All
接受健康志愿者

入选标准

  • confirmed treated or untreated renal cell carcinoma patients;
  • 68Ga-PSMA PET/CT and 18F-FDG PET/CT within two weeks;
  • signed written consent.

排除标准

  • pregnancy;
  • breastfeeding;
  • known allergy against PSMA
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance

研究组 & 干预措施

68Ga-PSMA, PET/CT and 177Lu-EB- PSMA-617 therapy

Experimental

All patients diagnosed with RCC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy.

干预措施: 68Ga-PSMA (Drug)

68Ga-PSMA, PET/CT and 177Lu-EB- PSMA-617 therapy

Experimental

All patients diagnosed with RCC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy.

干预措施: 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 (Drug)

结局指标

主要结局

Diagnostic value

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

Sensitivity and Specificity of 68Ga-PSMA PET/CT for Renal Cell Carcinoma in comparison with 18F-FDG PET/CT

次要结局

  • Safety of therapy(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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