Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University
About this trial
Study on the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET/CT in diagnosing primary, recurrent, and metastatic lesions of renal cell carcinoma; and investigate the effect of oral low-dose CAIX inhibitor (Acetazolamide) on the tissue distribution of 18F-NY104 in renal cell carcinoma patients, particularly in the stomach and kidneys.
Eligibility criteria
Qualifiers
Hematology: WBC ≥4.0×10⁹/L or neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90g/L; PT or APTT ≤1.5×ULN (upper limit of normal);
Liver and kidney function: T-Bil ≤1.5×ULN, ALT/AST ≤2.5×ULN or ≤5×ULN (for subjects with liver metastasis), ALP ≤2.5×ULN (if bone or liver metastasis present, ALP ≤4.5×ULN); BUN ≤1.5×ULN, SCr ≤1.5×ULN;
Other routine tests within normal ranges or deemed acceptable by the investigator; (7)Expected survival ≥12 weeks; (8) Female subjects: Effective contraception (defined as sterilization, intrauterine hormone device, condoms, contraceptives/agents, abstinence, or partner vasectomy) must be used during the study and for 6 months post-study; Male subjects: Agreement to use contraception during the study and for 6 months post-study.
Disqualifiers
Recovery from major trauma (including surgery) within 4 weeks prior to study examination;
Patients with systemic or local severe infections or other serious comorbidities;
Severe hepatic or renal dysfunction;
Refusal to participate in this clinical study;
Trial design
Treatments tested in this trial
- 18F-NY104 PET/CT
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
The Affiliated Hospital of Qingdao University
Lead sponsor
Qianfoshan Hospital
Collaborator
Weifang People's Hospital
Collaborator
Zibo Central Hospital
Collaborator
Jining Medical University
Collaborator
Source ClinicalTrials.gov