Prostate Cancer
Conditions
Interventions
Prostate cancer:Day 1 is the imaging day. The patient is intravenously injected with the 18F-PSMA imaging agent and undergoes a PET/CT scan, with an injection dose of approximately 0.08–0.15 mCi/kg (p
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male, aged =18 years and =80 years; 2. Histologically or cytologically confirmed prostate cancer patients; 3. Lesions identifiable by imaging (CT/MRI/PET), with suspected metastatic or recurrent sites; 4. Patient voluntarily participates and must sign a written informed consent form by the subject or their legal guardian, willing and able to comply with protocol requirements; 5. ECOG score 0-3, expected survival = 3 months; 6. Good renal function: eGFR = 30 mL/min/1.73 m²; 7. Liver function within acceptable limits: AST/ALT = 3×ULN, TBil = 2×ULN; 8. Blood counts meet test requirements: – Neutrophils = 1.5×10?/L – Platelets = 75×10?/L – Hemoglobin = 9 g/dL; 9. No anti-tumor treatment that could affect target expression (e.g., radiotherapy, targeted drugs) for at least 4 weeks prior to the study;
Exclusion criteria
Exclusion criteria: 1. Patients with severe other neurological diseases, or severe gastrointestinal, cardiovascular, liver, kidney, hematologic, respiratory, immune deficiency, or other serious diseases; 2. Patients who are allergic to the experimental drug, have a tendency to allergic reactions, or are allergic to multiple drugs; 3. In the past year, except for the radiation exposure expected from participation in this clinical study, have participated in other study protocols or clinical care that resulted in an effective radiation dose exceeding 50 mSv; 4. Have received (with uncertain efficacy or safety) experimental drugs or device treatments within the past month; 5. Patients with claustrophobia or other conditions that prevent cooperation or are unsuitable for PET examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events;Tumor-specific imaging capability of 68Ga-NY105; | — |
Secondary
| Measure | Time frame |
|---|---|
| the diagnostic efficacy of 68Ga-NY105 imaging for tumors; | — |
Countries
China
Contacts
Public ContactYi Heqing / Wang Zongping
Zhejiang Cancer Hospital
Outcome results
None listed