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NCT Number: NCT06205888

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

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.

Why the study stopped: No participants
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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-LNC1007(18F-FAPI-RGD) PET/CT和18F-FDG PET/CT

Other

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

Primary outcomes

  1. To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT;

    Time frame: 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 outcomes

  1. Compare the difference of the uptake of imaging agent between 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG injection in tumor lesions or metastases

    Time frame: 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

Other outcomes

  1. 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

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

To Compare the Clinical Application of 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG PET/CT in Tumor Diagnosis, Staging and Recurrence Detection

Acronym: 18F-LNC1007

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2024
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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