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Characterizing Histiocytosis With 68Ga-FAPI PET/CT

NCT05803629 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

  • Histiocytosis

Interventions

DIAGNOSTIC_TEST

68Ga-FAPI

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

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yaping Luo, MD · Peking Union Medical College Hospital

  • Li Huo, MD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-05-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05803629 on ClinicalTrials.gov