Status:
NOT_YET_RECRUITING
Clinical Application of PET Imaging Targeting Nectin-4 in Malignant Tumors
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Urothelial Carcinoma
Breast Cancer
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 expres...
Detailed Description
Malignant tumors are one of the major diseases leading to death worldwide, and their high incidence and mortality rates pose a serious threat to human health. According to the World Health Organizatio...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06994078
Start Date
July 1 2025
End Date
April 30 2026
Last Update
May 29 2025
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030