Determination of Molecular Status as Well as the Efficacy and Safety of Fluorodeoxyglucose (18F-FDG) in PET-CT Imaging in Juvenile Patients With Histiocytosis

  • STATUS
    Recruiting
  • End date
    Jun 23, 2026
  • participants needed
    150
  • sponsor
    Anna Raciborska
Updated on 8 July 2021

Summary

Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the tumor tissues, monitoring its presence in free-circulating DNA, and determining the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging.

Description

HISTIOGEN clinical study is part of the POL HISTIO project. The POL HISTIO project is a non-commercial clinical trial aimed at optimizing the diagnosis and treatment of juvenile patients with histiocytosis. The project objectives are defined as follows: 1) to estimate the nature and frequency of mutations in patients with histiocytosis in both tumor tissues and free-circulating DNA; 2) to compare molecular test results with clinical data; 3) to evaluate the diagnostic usefulness of the status of molecular analysis (MRD) as a prognostic factor compared with other recognized factors. As part of the HISTIOGEN protocol, an immortalized cell line will be derived to study the pathogenesis of the disease, drug sensitivity, and drug resistance mechanisms. The project is intended to include patients from all over Poland

Details
Condition Histiocytosis
Treatment fluorodeoxyglucose (18F-FDG)
Clinical Study IdentifierNCT04943211
SponsorAnna Raciborska
Last Modified on8 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient under 18 years of age at the time of inclusion
Histopatologically confirmed or suspected histiocytosis (based on prior test results)
Signing of informed consent for trial participation according with current legal regulations

Exclusion Criteria

Lack of inclusion criteria
Pregnancy
Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial
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