Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Urothelial Carcinoma Clinical Trial

Official title:

Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321316
• Other study ID #: 2022KT37
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Peking University Cancer Hospital & Institute
• Contact: Zhi Yang, Professor
• Phone: 010-88196495
• Email: pekyz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the ability of [68Ga]N188 to detect nectin-4 overexpression in patients with urothelial carcinoma, especially in patients with recurrent or advanced bladder cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old, male or female;

2. Heart function is normal;

3. Normal heart function;

4. Estimated survival =12 weeks;

5. Good follow-up compliance;

6. presence of at least one measurable target lesion according to RECIST1.1 criteria;

7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;

8. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;

9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

Exclusion Criteria:

1. Serious abnormality of liver, kidney and blood;

2. Pregnant patients;

3. Pregnant and lactation women;

3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• 18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value(SUV)	SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions? The uptake of the tracer (68Ga-N188) in urothelial carcinoma tumor lesions by measuring SUV on PET/CT.	2 years