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

ConditionPulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

suspected or confirmed pulmonary fibrosis patients;

signed written consent.

Disqualifiers

pregnancy;

breastfeeding;

known allergy against FAPI

any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Diagnostic value

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

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

FAPI expression and SUV

Correlation between FAPI expression and SUV in PET

Time frame
through study completion, an average of 1 year
2

therapy response

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

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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