68Ga-labeled NY108 PET Imaging in Patients

Prostatic Cancer Clinical Trial

Official title:

68Ga-labeled NY108 PET Imaging in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623878
• Other study ID #: LS2020005
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 4, 2022
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Affiliated Hospital of Jiangnan University
• Contact: Chunjing Yu
• Phone: 15312238622
• Email: ycj_wxd1978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 68Ga-labeled NY108
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY108.

Locations

Country	Name	City	State
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiangnan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108)	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.	1 year
Secondary	Incidence of Treatment-Emergent Adverse Events	Safety will be assessed by evaluation of incidence of adverse events.	1 year