This is a prospective, single-center, single-arm phase 2 study in patients with clear cell renal cell carcinoma and metastasis or recurrence suspicion. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in patients with clear cell renal cell carcinoma and metastasis or recurrence suspicion
This is a prospective, single-center, single-arm phase 2 study in patients with clear cell renal cell carcinoma and metastasis or recurrence suspicion. Each patient will receive one dose of 68Ga-NY104. Dedicated whole-body PET/CT imaging will be performed. PET/CT studies will be interpreted by two readers, both of whom will provide independent and blinded interpretations. Imaging interpretations and a composite ground truth will be used to estimate the diagnostic efficacy of 68Ga-NY104 PET/CT. A total of 40 patients will be recruited at Peking Union Medical College Hospital.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
Participants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGBinary reading of lesions identified on 68Ga-NY104 PET/CT
Any focal accumulation in the lesion suspected of metastasis or recurrence that cannot be explained by physiologic uptake of 68Ga-NY104 will be interpreted as PET positive.
Time frame: From study completion to 1 month after completion
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