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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275699
• Other study ID #: PUMCH-NM-FAPI-KELOID
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	FAPI expression and SUV	Correlation between FAPI expression and SUV in PET	through study completion, an average of 1 year
Secondary	therapy response	Change of 68Ga-FAPI PET/CT SUVmax after therapy	through study completion, an average of 1 year