Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT All patients diagnosed with Lung fibrosis underwent 68Ga-FAPI PET/CT and 18F-FDG PET/CT. |
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.
Other Names:
Drug: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Diagnostic value [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 Outcome Measures
- FAPI expression and SUV [through study completion, an average of 1 year]
Correlation between FAPI expression and SUV in PET
- therapy response [through study completion, an average of 1 year]
Decrease of 68Ga-FAPI PET/CT SUVmax after therapy
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Zhaohui Zhu, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PUMCH-NM-FAPI-PF