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NCT Number: NCT05321316

Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

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.

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Key information

Conditions

Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

18F-FDG

Drug

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

Primary outcomes

  1. Standardized uptake value（SUV）

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2022
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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