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68Ga-NY104 PET/CT Imaging in Patients With Confirmed or Suspicious Renal Cell Carcinoma
This is a prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma.
Two types of patients will be recruited in this study. Type 1, patients with renal masses scheduled for surgery, type 2, patients with confirmed or suspicious recurrent/metastatic ccRCC. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68G-NY104 PET/CT. 46 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Start Date
December 1, 2021
Primary Completion Date
July 1, 2023
Completion Date
July 1, 2023
Last Updated
June 15, 2023
46
ESTIMATED participants
68Ga-NY104 PET/CT
DIAGNOSTIC_TEST
Lead Sponsor
Peking Union Medical College Hospital
NCT07485114
NCT06391099
Data Source & Attribution
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