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NCT Number: NCT05121779

Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT

68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of Pulmonary fibrosis than 18F-FDG PET/CT.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

Pulmonary fibrosis is a prototype of chronic, progressive, and fibrotic lung disease.Healthy tissue is replaced by altered extracellular matrix and alveolar architecture is destroyed, which leads to decreased lung compliance, disrupted gas exchange, and ultimately respiratory failure and death.Pulmonary fibrosis is diagnosed by identification of a pattern of usual interstitial pneumonia on the basis of radiological or histological criteria in patients without evidence of an alternative cause. Activated fibroblasts are crucial for fibrotic processes in Pulmonary fibrosis. 68Ga-FAPI has been developed as a tumortargeting agent as fibroblast activation protein is overexpressed in cancerassociated fibroblasts and inflammation. Recently,a study shows that FAPI-PET/CT imaging is a promising new imaging modality for Pulmonary fibrosis.This head-to-head comparisons aims to evaluate the severity of pulmonary fibrosis and the therapy response of 68Ga-FAPI-04 compared with 18F-FDG in the same group of pulmonary fibrosis patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • suspected or confirmed pulmonary fibrosis patients;
  • signed written consent.

Exclusion criteria

  • pregnancy;
  • breastfeeding;
  • known allergy against FAPI
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Treatment and study plan

68Ga-FAPI

Drug

Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of pulmonary fibrosis by PET/CT.

Other names: 68Ga-fibroblast activating protein inhibitors

18F-FDG

Drug

Intravenous injection of one dosage of 4.44-5.55 MBq(0.12-0.15mCi)/Kg 18F-FDG. Tracer doses of 18F-FDG will be used to image lesions of pulmonary fibrosis by PET/CT.

Other names: 18F-Fluorodeoxyglucose

Primary outcomes

  1. Diagnostic value

    Time frame: through study completion, an average of 1 year

    Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 18F-FDG PET/CT

Secondary outcomes

  1. FAPI expression and SUV

    Time frame: through study completion, an average of 1 year

    Correlation between FAPI expression and SUV in PET

  2. therapy response

    Time frame: through study completion, an average of 1 year

    Change of 68Ga-FAPI PET/CT SUVmax after therapy

Study contacts

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

Jiarou Wang, MS

CONTACT

[email protected]

86-13628477019

Zhaohui Zhu, MD

CONTACT

[email protected]

86-13611093752

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2021
Registry last updated
Nov 25, 2024

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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