Characterizing Histiocytosis With 68Ga-FAPI PET/CT

Histiocytosis Clinical Trial

Official title:

Characterizing Histiocytosis With 68Ga-FAPI PET/CT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05803629
• Other study ID #: PekingUMCHFAPIhistiocytosis
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: Yaping Luo, MD
• Phone: 86-10-69155513
• Email: luoyaping[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Histiocytic disorders are rare diseases that are characterized by tissue infiltration of histiocytes (dendritic cells) and other inflammatory white blood cells. The archaic term "histiocyte" refers to large white blood cells resident in tissues and includes Langerhans cells, monocytes/macrophages, and dermal/interstitial dendritic cells. The Histiocytic Society classification divides histiocytic disorders into five categories, based on clinical, histologic, immunophenotypic, and molecular features. They are langerhans (L) group, cutaneous and mucocutaneous (C) group, Rosai-Dorfman disease (R) group, malignant histiocytosis (M) group and hemophagocytic lymphohistiocytosis (H) group. Langerhans cell histiocytosis is the most common histiocytic disorder. Less common types include Erdheim-Chester disease, Rosai-Dorfman disease, adult and juvenile xanthogranuloma. Diagnosis, which relies on a multidisciplinary approach, is challenging and often delayed because clinical findings are nonspecific and may mimic malignant processes at radiologic evaluation. Compared with conventional imaging, PET/CT allows detection of the increased metabolic activity in histiocytes and provides a comprehensive whole-body evaluation of their potential involvement with multiple organ systems and allows monitoring of therapeutic response. However, one drawback is that the uptake of FDG is nonspecific because histiocytic lesions may mimic neoplastic processes at PET/CT. And the physiological FDG metabolism in brain, liver and gastrointestinal tract, et al. hampers the detection rate of lesions located in these organs.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. Although the pathogenesis of histiocytosis may be attributable to mutations in the oncogenic driver, recent discoveries have shown that inflammation and fibrosis secondary to mutated histiocytes, rather than a proliferative cell mechanism, result in manifestation of the disease. Considering 68Ga-FAPI revealing cancer-associated fibroblasts, 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Histiocytosis

Intervention

Diagnostic Test:
• 68Ga-FAPI
Intravenous injection of one dosage of 74-148 MBq(2-4 mCi) 68Ga-FAPI.
• 18F-FDG
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.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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