Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 2, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedJune 23, 2023
February 1, 2023
11 months
March 2, 2022
June 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
FAPI expression and SUV
through study completion, an average of 1 year
therapy response
through study completion, an average of 1 year
Study Arms (1)
68Ga-FAPI-04 PET/CT
EXPERIMENTALAll patients diagnosed with keloid underwent 68Ga-FAPI PET/CT.
Interventions
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.
Eligibility Criteria
You may qualify if:
- suspected or confirmed pulmonary fibrosis patients;
- signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
Wang J, Yu N, Wang G, Wang R, Li L, Jiang Y, Sui H, Sun Y, Li Z, Long X, Zhu Z. 68 Ga-FAPI-04 PET/CT in Assessment of Fibroblast Activation in Keloids : A Prospective Pilot Study. Clin Nucl Med. 2024 Jan 1;49(1):16-22. doi: 10.1097/RLU.0000000000004913. Epub 2023 Nov 24.
PMID: 38015039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaohui Zhu, MD
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2022
First Posted
March 11, 2022
Study Start
March 1, 2022
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
June 23, 2023
Record last verified: 2023-02