Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-FDG.
- Who it may be relevant to
- Registry conditions: Urothelial Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug 18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan.
Primary outcome measures
- Standardized uptake value（SUV） [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 18-75 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.
Exclusion criteria
- Serious abnormality of liver, kidney and blood;
- Pregnant patients;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT05321316 · 2022KT37