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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05121779
Other study ID # PUMCH-NM-FAPI-PF
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date December 1, 2021
Est. completion date December 1, 2023

Study information

Verified date November 2021
Source Peking Union Medical College Hospital
Contact Zhaohui Zhu, MD
Phone 86-13611093752
Email 13611093752@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
68Ga-FAPI
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.
18F-FDG
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.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic value Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 18F-FDG PET/CT through study completion, an average of 1 year
Secondary FAPI expression and SUV Correlation between FAPI expression and SUV in PET through study completion, an average of 1 year
Secondary therapy response Decrease of 68Ga-FAPI PET/CT SUVmax after therapy through study completion, an average of 1 year
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