18F-FAPI PET in Lung Cancer

Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Lung Cancers

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer (Diagnosis)
• Intervention / Treatment: Diagnostic test: 18F-FAPI PET

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Donghe Chen, MD; Phone Number: 0571-87236432; Email: chendonghe@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Donghe Chen Chen; Phone Number: 0571-87236431; Email: chendonghe@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

120

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FAPI-Lung-ca; 18F FAPI PET scans	Diagnostic test: 18F-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic efficacy	Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET Imaging in lung cancer.	through study completion, an average of 1.5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard uptake value （SUV）of tumor	This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean).	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）	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）	through study completion, 3-4 years

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Study Director: Donghe Chen, MD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease
• Other Study ID Numbers: FirstZhejiangU-FAPI-Lung Ca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED