Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT

Study Overview
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Brief Summary
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Keloid scars are common benign fibroproliferative reticular dermal lesions. Fibroblasts are considered to be the key cellular mediators of fibrogenesis in keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may provide evidence for diagnosis and evaluate the effectiveness of treatment.

Detailed Description
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Keloid scars are common benign fibroproliferative reticular dermal lesions with unknown etiology and ill-defined management with a high rate of recurrence post-surgery. The progression of keloids is characterized by increased deposition of extracellular matrix proteins, invasion of the surrounding healthy skin, and inflammation. Fibroblast activation protein alpha (FAP-a) and dipeptidyl peptidase IV(DPPIV) are proteases located at the plasma membrane promoting cell invasiveness and tumor growth and have been previously associated with keloid scars. 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 keloid. This study aims to explore whether FAP plays a role in the mechanisms of scar tissue progression, as well as the diagnostic efficacy of these two imaging agents, and to be able to evaluate relevant treatments for personalized therapy.

Official Title
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Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT

Conditions
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Keloid

Intervention / Treatment
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* Drug: 68Ga-FAPI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI-04 PET/CT<br>All patients diagnosed with keloid underwent 68Ga-FAPI PET/CT. | Drug: 68Ga-FAPI<br>* 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 keloid by PET/CT.<br>* Other names: 68Ga-fibroblast activating protein inhibitors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value | Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 68Ga-RGD PET/CT | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAPI expression and SUV | Correlation between FAPI expression and SUV in PET | through study completion, an average of 1 year | 
| therapy response | Change of 68Ga-FAPI PET/CT SUVmax after therapy | through study completion, an average of 1 year |