Clinical trial
Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT
Name
PUMCH-NM-FAPI-KELOID
Description
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.
Trial arms
Trial start
2022-03-01
Estimated PCD
2023-02-01
Trial end
2023-02-01
Status
Completed
Phase
Early phase I
Treatment
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 keloid by PET/CT.
Arms:
68Ga-FAPI-04 PET/CT
Other names:
68Ga-fibroblast activating protein inhibitors
Size
25
Primary endpoint
Diagnostic value
through study completion, an average of 1 year
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2023-06-23
1 organization
1 product
1 indication
Organization
Peking Union Medical College HospitalProduct
68Ga-FAPIIndication
Keloid