RecruitingPhase 1NCT05121779

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


Sponsor

Peking Union Medical College Hospital

Enrollment

80 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

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

Exclusion Criteria4

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

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Interventions

DRUG68Ga-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.

DRUG18F-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(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT05121779


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