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NCT Number: NCT07370805

18F-FAPI PET in Lung Cancer

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

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location contact

Donghe Chen Chen

CONTACT

[email protected]

0571-87236431

About this study

  • 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.
  • 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.).
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-FAPI PET

Diagnostic 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.

Primary outcomes

  1. Diagnostic efficacy

    Time frame: 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 outcomes

  1. Standard uptake value (SUV)of tumor

    Time frame: through study completion, 3-4 years

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

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

    Time frame: through study completion, 3-4 years

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

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Donghe Chen, MD

CONTACT

[email protected]

0571-87236432

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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