Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Application of PET Imaging Targeting Nectin-4 in Malignant Tumors
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-07-01
Completion Date
2026-04-30
Last Updated
2025-05-29
Healthy Volunteers
Yes
Interventions
68Ga-NOTA-Nectin-4 antibody fragment
To perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed urothelial carcinoma, breast cancer, lung carcinoma and other malignant tumors with high Nectin-4 expression and healthy volunteers, using specific positron imaging agents targeting Nectin-4 (taking \[68Ga\]Ga-NOTA-Nectin-4 antibody fragment as an example), to achieve the following purposes: Patients with malignant tumors: for diagnosis and staging of diseases, comparing with the gold standard pathological diagnosis, evaluating diagnostic efficacy, clarifying the presence or absence of lesions, and determining the location and nature of lesions; comparing with \[18F\]FDG PET for accurate staging, evaluating the tumor load, and helping to determine the therapeutic plan. Healthy volunteers: Pharmacokinetic analysis will be performed to clarify the distribution and metabolism of the drug in the body and its safety.
Locations (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China