Clincosm LogoSign in Get a demo

Head-to-head Comparison of Diagnosis Value of Keloid on 68Ga- FAPI-04 and 68Ga-RGD PET-CT

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05275699
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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. The αvβ3 integrin is a key mediator of angiogenesis and thus may be an important diagnostic and therapeutic target associated with active keloid development processes. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT and/or 68Ga-RGD PET/CT may provide evidence for diagnosis and evaluate the effectiveness of treatment.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 into 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.

Integrin αvβ3 is an important member of the integrin receptor family and expressed preferentially on regenerative vascular endothelial cells and some tumor cells, but no or very low expressed on the quiescent vessel cells and other normal cells. The αvβ3 integrin is a key mediator of angiogenesis and thus may be an important diagnostic and therapeutic target associated with active keloid development processes.

This study aims to explore whether FAP and angiogenesis play 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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Head-to-head Comparison of Diagnosis Value of Keloid on 68Ga- FAPI-04 and 68Ga-RGD PET-CT
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-FAPI-04 PET/CT and 68Ga-RGD PET/CT

All patients diagnosed with keloid underwent 68Ga-FAPI PET/CT and 68Ga-RGD PET/CT.

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.
Other Names:
  • 68Ga-fibroblast activating protein inhibitors

    • Drug: (68)Ga-RGD
    Intravenous injection of one dosage of 111 MBq 68Ga-RGD. Tracer doses of 68Ga-RGD will be used to image keloid area by positron emission tomography / computed tomography (PET/CT)
    Other Names:
  • 68Ga-arginine-glycine-aspartic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. Number of participants with adverse events [through study completion, an average of 1 year]

      Adverse events within 5 days after 68GaRGD injection and PET/CT scanning of the patients will be collected and assessed.

    Secondary Outcome Measures

    1. FAPI expression and SUV [through study completion, an average of 1 year]

      Correlation between FAPI expression and SUV in PET

    2. RGD expression and SUV [through study completion, an average of 1 year]

      Correlation between RGD expression and SUV in PET

    3. therapy response [through study completion, an average of 1 year]

      Change of 68Ga-FAPI PET/CT SUVmax after therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • suspected or confirmed pulmonary fibrosis patients;

    • signed written consent.

    Exclusion Criteria:

    • pregnancy;

    • breastfeeding;

    • known allergy against FAPI or RGD

    • any medical condition that in the opinion of the investigator may significantly interfere with study compliance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Zhaohui Zhu, MD, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05275699
    Other Study ID Numbers:
    • PUMCH-NM-FAPI-KELOID
    First Posted:
    Mar 11, 2022
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Keloid
    Glycine

    Study Results

    No Results Posted as of Mar 11, 2022