Histiocytosis Clinical Trial
Official title:
Characterizing Histiocytosis With 68Ga-FAPI PET/CT
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - suspected or confirmed untreated histiocytosis patients - 18F-FDG PET/CT within two weeks; - signed written consent. Exclusion Criteria: - pregnancy; - breastfeeding; - known allergy against FAPI |
Country | Name | City | State |
---|---|---|---|
China | Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Metabolic parameters | Total Lesion Glycolysis (TLG) of histiocytosis lesions are measured on 68Ga-FAPI 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 | Disease burden assessement | Correlation between Total Lesion Glycolysis (TLG) of histiocytosis lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for histiocytosis | through study completion, an average of 1 year | |
Secondary | therapy response | Decrease of Total Lesion Glycolysis (TLG) on 68Ga-FAPI PET/CT after therapy | through study completion, an average of 1 year |
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