To Compare the Clinical Application of 18F-LNC1007 Injection PET/CT and 18F-FDG PET/CT

Not yet recruiting

• Conditions: Tumour
• Interventions: Other: 18F-LNC1007（18F-FAPI-RGD） PET/CT和18F-FDG PET/CT

• Registration Number: NCT06205888
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Study Start: 2024-03-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Compare 18F-LNC1007 injection (18F-FAPI-RGD) PET/CT and 18F-FDG PET/CT imaging	18F-LNC1007（18F-FAPI-RGD） PET/CT和18F-FDG PET/CT	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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