68Ga-labeled NY108 PET Imaging in Patients

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY108 (89Zr-NY108) PET Imaging in patients with .

• 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;

3. Patients diagnosed with prostatic cancer confirmed by histopathology or cytology;

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

5. Patients with biopsy-proven PSMA positive;

6. 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 allergies or allergies to any component of the imaging agent or antibody;

4. Patients who cannot perform PET/CT imaging scan;

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

6. Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation;

7. Uncontrolled hypertension;

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

9. Male subjects of reproductive age cannot take effective contraceptive measures;

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

11. Other subjects considered unsuitable by researchers.