Status:
ACTIVE_NOT_RECRUITING
Clinical Application of FL-091 Radionuclide Imaging in Diagnosis and Staging of Malignant Tumors
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Malignant Tumors With Positive NTSR1 Expression
Eligibility:
All Genders
18+ years
Brief Summary
Malignant tumors pose a serious threat to human health, and early diagnosis and early treatment are crucial to improving the patient's prognosis. Nuclear medicine imaging technology injects radioisoto...
Eligibility Criteria
Inclusion
- Each subject must meet all enrollment criteria to be eligible to participate in the study:
- The subject or his/her legal representative is able to sign and date the informed consent form;
- A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
- Adult patients or healthy volunteers (aged 18 or above) of either sex;
- Patients with clinically suspected or confirmed malignant tumors such as head and neck cancer, colorectal cancer, or pancreatic cancer (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;
- Consistent with the results of specific laboratory tests;
- 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；
- Other set entry criteria.
Exclusion
- All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
- Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
- Having other comorbidities;
- Patients with known hypersensitivity to FL-091 fragment developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
- Have a history of comorbid drug use;
- Patients considered by the investigator to have poor compliance;
- Patients during pregnancy or lactation;
- Persons with other factors that make participation in this test inappropriate.
Key Trial Info
Start Date :
October 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06977945
Start Date
October 25 2024
End Date
October 1 2026
Last Update
May 18 2025
Active Locations (1)
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1
Wuhan Union Hospital,China
Wuhan, Hubei, China, 430030