Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
May 31, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
Study Completion
Last participant's last visit for all outcomes
December 1, 2026
March 4, 2026
March 1, 2026
6 months
April 4, 2022
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
68Ga-N188
EXPERIMENTALImaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-N188 PET/CT scan.
Interventions
Eligibility Criteria
You may qualify if:
- years old, male or female;
- Heart function is normal;
- Normal heart function;
- Estimated survival ≥12 weeks;
- Good follow-up compliance;
- presence of at least one measurable target lesion according to RECIST1.1 criteria;
- 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;
- Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
- The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.
You may not qualify if:
- Serious abnormality of liver, kidney and blood;
- Pregnant patients;
- Pregnant and lactation women;
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 11, 2022
Study Start (Estimated)
May 31, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share