68Ga-labeled NY104 PET Imaging in Patients

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY104 PET Imaging in patients with Renal Cell Carcinoma

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of Jiangnan University

Criteria

Inclusion Criteria:

1. Patients voluntarily signed informed consent;

2. Age 18-75, male or female;

3. Patients diagnosed with renal cell carcinoma confirmed by histopathology or cytology;

4. At least one measurable solid lesion has been examined according RECIST1.1 standard;

5. ECOG score 0~3; Life expectancy of at least 3 months;

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;

2. Patients with systemic or locally severe infections, or other serious coexisting diseases;

3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;

4. Patients with autoimmune diseases, including rheumatoid arthritis;

5. Inadequate control of arrhythmias, including atrial fibrillation;

6. Uncontrolled hypertension;

7. Patients with allergies or allergies to any component of the imaging agent or antibody;

8. Patients who cannot undergo PET/CT imaging scan;

9. Syphilis, HBV, HCV, or HIV positive subjects;

10. Male and female subjects of reproductive age cannot take effective contraceptive measures;

11. Pregnant or lactating women;

12. Patients with a history of mental illness or related conditions;

13. Other subjects considered unsuitable by researchers.