18F-FAPI PET in Lung Cancer

N/ANot Yet RecruitingNCT07370805

First Affiliated Hospital of Zhejiang University120 enrolled

Overview

This study aims to evaluate the diagnostic efficacy and prognostic value of 18F-FAPI PET/CT in lung cancer.

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Lung Cancer (Diagnosis)

Interventions

18F-FAPI PETDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Diagnostic efficacy

Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET Imaging in lung cancer.

Time frame: through study completion, an average of 1.5 year

Secondary Outcomes

Standard uptake value （SUV）of tumor

This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean).

Time frame: through study completion, 3-4 years

Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor

This measure evaluates the association between baseline 18F-FAPI PET parameters (MTV in cm3, TLG in cm3\*SUV）

Time frame: through study completion, 3-4 years

Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients

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）

Time frame: through study completion, 3-4 years

Central Contacts

Donghe Chen, MD

CONTACT

0571-87236432 chendonghe@zju.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.