Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Brief Title

Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Official Title

Nectin-4 Specific LMW PET Probe Imaging in 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.

Study Type

Interventional

Primary Outcome

Standardized uptake value（SUV）

Condition

Urothelial Carcinoma

Intervention

18F-FDG

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 2022

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 010-88196495, [email protected]

Administrative Informations

NCT ID

NCT05321316

Organization ID

2022KT37

Responsible Party

Principal Investigator

Study Sponsor

Beijing Cancer Hospital

Study Sponsor

, ,

Verification Date

April 2022