68Ga-labeled NY104 PET Imaging in Patients

Renal Cell Carcinoma Clinical Trial

Official title:

68Ga-labeled NY104 PET Imaging in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638256
• Other study ID #: LS2020003
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 10, 2022
• Est. completion date: October 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 NY104 PET Imaging in patients with Renal Cell Carcinoma

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• 68Ga-NY104
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY104

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-NY104	Biodistribution of 68Ga-NY104 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.	1 year