Clinical Trials in China / NCT05321316
Recruiting
Not applicable
Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
NCT05321316 · tracked via the Priya Life Science China tracker
Condition(s) studied
Urothelial Carcinoma
Investigational drug(s) / intervention(s)
18F-FDG: All study participants will undergo one 18F-FDG PET/CT scan.
Study 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.
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.
Primary outcome measure(s)
- 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 sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05321316 on ClinicalTrials.gov ↗ ← All trials in China