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

Phase 1

Completed

• Conditions: Keloid
• Interventions: Drug: 68Ga-FAPI

• Registration Number: NCT05275699
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Status Verified: 2023-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI-04 PET/CT	68Ga-FAPI	All patients diagnosed with keloid underwent 68Ga-FAPI PET/CT.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China