Health Trials

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 group

Locations

1
The Affiliated Hospital of Qingdao University QingdaoShandong, China

Sponsors 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