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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Completed
Phase 2
Phase 1

Conditions

Keloid

Treatments

Drug: 68Ga-FAPI

Study type

Interventional

Funder types

Other

Identifiers

NCT05275699
PUMCH-NM-FAPI-KELOID

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

68Ga-FAPI-04 PET/CT
Experimental group
Description:
All patients diagnosed with keloid underwent 68Ga-FAPI PET/CT.
Treatment:
Drug: 68Ga-FAPI

Trial contacts and locations

1

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Central trial contact

Jiarou Wang, MS; Zhaohui Zhu, MD

Data sourced from clinicaltrials.gov

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