Characterizing Histiocytosis With 68Ga-FAPI PET/CT
1 other identifier
interventional
100
1 country
1
Brief Summary
Histiocytic disorders are rare diseases that are characterized by tissue infiltration of histiocytes (dendritic cells) and other inflammatory white blood cells.68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and it might be a pan-tumor PET agent.Recent discoveries have shown that inflammation and fibrosis secondary to mutated histiocytes, rather than a proliferative cell mechanism, result in manifestation of the disease.Thus, the investigators aim to carry out this prospective study to investigate the role of 68Ga-FAPI PET/CT in the diagnosis, therapy response assessment and follow-up of histiocytosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
March 25, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 18, 2023
March 1, 2023
2.1 years
March 25, 2023
April 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic value
Sensitivity and Specificity of 68Ga-FAPI PET/CT for histiocytosis in comparison with 18F-FDG PET/CT
through study completion, an average of 1 year
Secondary Outcomes (4)
Metabolic parameters
through study completion, an average of 1 year
FAPI expression and SUV
through study completion, an average of 1 year
Disease burden assessement
through study completion, an average of 1 year
therapy response
through study completion, an average of 1 year
Study Arms (1)
68Ga-FAPI ,PET/CT
EXPERIMENTALInject 68Ga-FAPI and then perform PET/CT scan.
Interventions
Intravenous injection of one dosage of 74-148 MBq(2-4 mCi) 68Ga-FAPI.
Intravenous injection of one dosage of 7.4MBq/kg(0.2mCi/kg) 18F-FDG. 18F-FDG PET/CT is performed within one week from 68Ga-FAPI PET/CT scan.
Eligibility Criteria
You may qualify if:
- suspected or confirmed untreated histiocytosis patients
- F-FDG PET/CT within two weeks;
- signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- known allergy against FAPI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaping Luo, MD
Peking Union Medical College Hospital
- STUDY CHAIR
Li Huo, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2023
First Posted
April 7, 2023
Study Start
May 1, 2023
Primary Completion
May 31, 2025
Study Completion
December 31, 2025
Last Updated
April 18, 2023
Record last verified: 2023-03