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Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05321316
Enrollment
20
Registered
2022-04-11
Start date
2026-05-31
Completion date
2026-12-01
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

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.

Interventions

DRUG18F-FDG

All study participants will undergo one 18F-FDG PET/CT scan.

Sponsors

Peking University Cancer Hospital & Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Standardized uptake value(SUV)2 yearsSUV 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.

Countries

China

Contacts

CONTACTZhi Yang, Professor
pekyz@163.com010-88196495
CONTACTHua Zhu, Professor
zhuhuabch@pku.edu.cn010-88196495

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026