PET Imaging Test for Nectin-4 Protein in Certain Cancers

Trial details

Who runs it

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Trial code

NCT06994078

Record updated

29 May 2025

Original description

This study is a diagnostic study. Patients and healthy volunteers with clinically suspected or confirmed urothelial carcinoma, breast cancer, lung carcinoma and other malignant tumors with high expression of Nectin-4 will be recruited for PET/MR or PET/CT imaging targeting a Nectin-4-specific probe (in the case of [68Ga]Ga-NOTA-Nectin-4 antibody fragment) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET imaging in patients with contraindications. General information on the subjects' vital signs, clinical data, blood routine, liver and kidney functions and other biochemical indicators and other imaging data were collected, and histopathology of biopsy or surgical specimens was used as the final diagnostic criterion.Read full original descriptionShow less

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

This study is a diagnostic study. Patients and healthy volunteers with clinically suspected or confirmed urothelial carcinoma, breast cancer, lung carcinoma and other malignant tumors with high expression of Nectin-4 will be recruited for PET/MR or PET/CT imaging targeting a Nectin-4-specific probe (in the case of [68Ga]Ga-NOTA-Nectin-4 antibody fragment) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET imaging in patients with contraindications. General information on the subjects' vital signs, clinical data, blood routine, liver and kidney functions and other biochemical indicators and other imaging data were collected, and histopathology of biopsy or surgical specimens was used as the final diagnostic criterion.

Inclusion: 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: 4: Have a history of comorbid drug use; 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；; 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; 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.

ClinicalTrials.gov NCT06994078