Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Not Applicable

Recruiting

• Conditions: Urothelial Carcinoma
• Interventions: Drug: 18F-FDG

• Registration Number: NCT05321316
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-11
• Study Start: 2022-05-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-N188	18F-FDG	Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-N188 PET/CT scan.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value（SUV）	2 years	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.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China