Clinical trial NCT06205888: To Compare the Clinical Application of 18F-LNC1007 Injection PET/CT and 18F-FDG PET/CT
Official title: To Compare the Clinical Application of 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG PET/CT in Tumor Diagnosis, Staging and Recurrence Detection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tumour
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient with a clinically suspected or confirmed tumor

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT;
timeFrame: 3 months
Secondary outcomes:
measure: Compare the difference of the uptake of imaging agent between 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG injection in tumor lesions or metastases
timeFrame: 3 months
Other outcomes:
measure: The type, incidence, and severity of adverse events were graded using the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI CTCAE) V5.0 standard
timeFrame: 3 months
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