Keloid
Conditions
Brief summary
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
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.
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 keloid by PET/CT.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic value | through study completion, an average of 1 year | Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 68Ga-RGD PET/CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Change of 68Ga-FAPI PET/CT SUVmax after therapy |
Countries
China
Outcome results
None listed