Clinical trial · Interventional
Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
NCT05321316CI-TRIAL-00104631recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-N188
- description
- Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-N188 PET/CT scan.
- interventionNames
- Drug: 18F-FDG
Primary outcomes (1)
- measure
- Standardized uptake value（SUV）
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.