Prostatic Cancer
Conditions
Brief summary
This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.
Interventions
DRUG68Ga-labeled NY108
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY108.
Sponsors
Affiliated Hospital of Jiangnan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108) | 1 year | Biodistribution of 68Ga-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 1 year | Safety will be assessed by evaluation of incidence of adverse events. |
Countries
China
Contacts
Primary ContactChunjing Yu
Outcome results
None listed