Lung Cancer (Diagnosis)
Conditions
Brief summary
This study aims to evaluate the diagnostic efficacy and prognostic value of 18F-FAPI PET/CT in lung cancer.
Detailed description
1. Patients clinically suspected or confirmed with lung cancer are required to complete conventional imaging examinations (CT/MR or FDG PET) and undergo ¹⁸F-FAPI PET/CT. 2. Conduct a detailed inquiry into the patient's medical history to clarify symptoms, signs, and prior medical history (e.g., tumor history, surgical history, biopsy history, radiotherapy history, chemotherapy history, family history, allergy history, etc.), as well as relevant laboratory tests and previous imaging findings (including plain radiography, ultrasound, CT, MRI, 18F-FDG PET/CT, PET/MR, etc.). 3. For follow-up coordination, you are required to regularly provide your clinical data (e.g., treatment plans, disease progression, etc.) as per the study requirements. This collaboration is essential for completing long-term follow-up, including monitoring the subject's condition, imaging findings, pathological results (such as tumor grading and Ki-67 index), and patient treatment outcomes, to collect prognostic information. 4. ¹⁸F-FAPI PET/CT and conventional imaging examinations (e.g., CT/MR) were completed prior to enrollment. After enrollment in this study, subjects were not required to undergo additional imaging or laboratory tests, only requiring follow-up without intervention to the clinical treatment plan.
Interventions
DIAGNOSTIC_TEST18F-FAPI PET
1、Patients clinically suspected or confirmed with lung cancer are required to complete conventional imaging examinations (CT/MR or FDG PET) and undergo ¹⁸F-FAPI PET/CT.
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of Lung Cancer 2. With 18F FAPI PET scan
Exclusion criteria
1. Concurrent presence of other active malignant tumors or a history of other 2. malignant tumors within the past 5 years; 3. Severe uncontrollable diseases or active infections; 4. Ineligible participants for project informed consent； 5. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy | through study completion, an average of 1.5 year | Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET Imaging in lung cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard uptake value （SUV）of tumor | through study completion, 3-4 years | This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean). |
| Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor | through study completion, 3-4 years | This measure evaluates the association between baseline 18F-FAPI PET parameters (MTV in cm3, TLG in cm3\*SUV） |
| Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients | through study completion, 3-4 years | PFS will be defined as the time from diagnosis to disease progression or relapse, assessed using the Kaplan-Meier method and Cox proportional hazards model.（PFS in months） |
Countries
China
Contacts
CONTACTDonghe Chen, MD
STUDY_DIRECTORDonghe Chen, MD
Zhejiang University
Outcome results
None listed