Clinical Application of PET Imaging Targeting Nectin-4 in Malignant Tumors

Launched by WUHAN UNION HOSPITAL, CHINA · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to use PET imaging to help detect and understand certain types of cancer, specifically urothelial carcinoma (a type of bladder cancer), breast cancer, and lung carcinoma. Researchers will be using a special imaging technique that targets a protein called Nectin-4, which is often found in high amounts in these cancers. The goal is to see how well this imaging method works for diagnosing and staging these tumors, as well as to monitor how the body reacts to the injected imaging agent.

To participate in this study, individuals must be at least 18 years old and either have a suspected or confirmed diagnosis of one of the targeted cancers or be a healthy volunteer. Participants will need to be able to cooperate with the study procedures, and women of childbearing age must use contraception during the study. During the trial, participants can expect to undergo PET/MR or PET/CT scans and provide information about their health and any other medical tests that have been done. Importantly, those with certain health issues or who have trouble with imaging tests may not be eligible to join. This trial is not yet recruiting, but it aims to provide valuable information about a promising new diagnostic tool for cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Each subject must meet all enrollment criteria to be eligible to participate in the study:
• • 1: The subject or his/her legal representative is able to sign and date the informed consent form;
• • 2: A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
• • 3: Adult patients or healthy volunteers (aged 18 or above) of either sex;
• • 4: Patients with clinically suspected or confirmed malignant tumors such as urothelial carcinoma, breast cancer and lung carcinoma (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;
• • 5: Consistent with the results of specific laboratory tests;
• • 6: Females of childbearing potential who have been using contraception for at least one month prior to screening and who are committed to using contraception for the entire study period and until a specified time after the end of the study；
• • 7: Other set entry criteria.
• Exclusion Criteria:
• All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
• • 1: Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
• • 2: Having other comorbidities;
• • 3: Patients with known hypersensitivity to Nectin-4 antibody fragment developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
• • 4: Have a history of comorbid drug use;
• • 5: Patients considered by the investigator to have poor compliance;
• • 6: Patients during pregnancy or lactation;
• • 7: Persons with other factors that make participation in this test inappropriate.