To Compare the Clinical Application of 18F-LNC1007 Injection PET/CT and 18F-FDG PET/CT (18F-LNC1007)
August 6, 2026 updated by: Jiang Wu, Jinling Hospital, China
To Compare the Clinical Application of 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG PET/CT in Tumor Diagnosis, Staging and Recurrence Detection
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
A patient with a clinically suspected or confirmed tumor
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Compare 18F-LNC1007 injection (18F-FAPI-RGD) PET/CT and 18F-FDG PET/CT imaging
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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;
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
January 4, 2024
First Submitted That Met QC Criteria
January 4, 2024
First Posted (Actual)
January 16, 2024
Study Record Updates
Last Update Posted (Actual)
August 10, 2026
Last Update Submitted That Met QC Criteria
August 6, 2026
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18F-LNC1007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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