Tumour
Conditions
Brief summary
To evaluate the safety of 18F-LNC1007 injection in the diagnosis of suspected tumor, initial stage, or recurrence monitoring; to explore the biological distribution of 18F-LNC1007 injection in patients; To compare the diagnostic efficacy of 18F-LNC1007 injection PET/CT versus 18F-FDG PET/CT imaging in patients with tumor with clinical suspicion, initial stage, or recurrence monitoring.
Detailed description
This is a prospective, controlled, open-label (with blind members), single-center clinical trial to evaluate the diagnostic efficacy and safety of 18F-LNC1007 injection PET/CT for suspected tumor or tumor initial staging, recurrence monitoring, etc.
Interventions
OTHER18F-LNC1007（18F-FAPI-RGD） PET/CT和18F-FDG PET/CT
Eligible subjects will receive 18F-LNC1007 (18F-FAPI-RGD) PET/CT and 18F-FDG PET/CT examinations within 1 week (the interval between the two examinations shall not exceed 7 days, and the scanning parameters, scanning range, image reconstruction methods, etc., shall be consistent). That is, with 18F-LNC1007 (18F-FAPI-RGD) PET/CT time as D0, 18F-FDG PET/CT examination can accept data from D1 to D7
Sponsors
Jinling Hospital, China
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1) Age ≥18 years old; (2) Clinically suspected or confirmed tumor patients; (3) As judged by doctors, the expected survival time is 3 months; (4) Voluntarily sign informed consent; (5) Willing and able to follow the research protocol; (6) The subject must be able to lie on the scanning bed for at least 1 hour.
Exclusion criteria
* (1) known allergic history to 18F-LNC1007 injection; (2) Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history); (3) Those who are not suitable for PET/CT and other imaging examinations or cannot complete them due to special reasons, including claustrophobia and radiophobia; (4) pregnant and lactating women; (5) Workers who are exposed to radiation for a long period of time; (6) serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis; (7) Participating in other interventional clinical trials within 1 month before screening; (8) Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy; (9) There are other circumstances that the researcher considers inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT; | 3 months | To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the difference of the uptake of imaging agent between 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG injection in tumor lesions or metastases | 3 months | Compare the difference of the uptake of imaging agent between 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG injection in tumor lesions or metastases |
Outcome results
None listed