Characterizing Histiocytosis With 68Ga-FAPI PET/CT

NCT ID: NCT05803629

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-12-31

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.

Detailed 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.

Conditions

Histiocytosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-FAPI ,PET/CT

Inject 68Ga-FAPI and then perform PET/CT scan.

Group Type: EXPERIMENTAL

68Ga-FAPI

Intervention Type: DIAGNOSTIC_TEST

Intravenous injection of one dosage of 74-148 MBq(2-4 mCi) 68Ga-FAPI.

18F-FDG

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

68Ga-FAPI

Intravenous injection of one dosage of 74-148 MBq(2-4 mCi) 68Ga-FAPI.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

68Ga-fibroblast activating protein inhibitors

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaping Luo, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Li Huo, MD

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science

Beijing, , China

Countries

China

Central Contacts

Yaping Luo, MD

Role: CONTACT

luoyaping@live.com

86-10-69155513

Qingqing Pan, MD

Role: CONTACT

pqqelvay@126.com

86-10-69155513

Other Identifiers

PekingUMCHFAPIhistiocytosis

Identifier Type: -

Identifier Source: org_study_id