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18F-FAPI PET in Lung Cancer

Observational Lung Cancer (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-FAPI PET.
Who it may be relevant to
Registry conditions: Lung Cancer (Diagnosis). Basic parameters: 20 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 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.

Primary outcome measures

  • Diagnostic efficacy [Time frame: through study completion, an average of 1.5 year]
Secondary outcome measures (3)
  • Standard uptake value (SUV)of tumor [Time frame: through study completion, 3-4 years]
  • Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor [Time frame: through study completion, 3-4 years]
  • Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients [Time frame: through study completion, 3-4 years]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of Lung Cancer
  • With 18F FAPI PET scan

Exclusion criteria

  • Concurrent presence of other active malignant tumors or a history of other
  • malignant tumors within the past 5 years;
  • Severe uncontrollable diseases or active infections;
  • Ineligible participants for project informed consent;
  • Pregnant and lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07370805 · FirstZhejiangU-FAPI-Lung Ca

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗