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NCT Number: NCT04943211

Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mother and Child Institute

Warsaw, Mazovian, 01-211, Poland

Location status: Recruiting

Location contact

Anna Raciborska

PRINCIPAL_INVESTIGATOR

Katarzyna Maleszewska

CONTACT

[email protected]

+48 22 32 77 205

About this study

HISTIOGEN clinical study is part of the POLHISTIO project. The POLHISTIO 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient under 18 years of age at the time of inclusion.
  • Histopathologically 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.

Treatment and study plan

fluorodeoxyglucose (18F-FDG)

Drug

max 6 MGBq/kg, no more than 100

Other names: GLUNEKTIK; SYNEKTIK

Primary outcomes

  1. EFS - (event-free survival)

    Time frame: 2 years

    Event-free survival (EFS) was defined as the time interval from the date of diagnosis to the date of disease progression, recurrence, second malignancy, death or to date of last follow-up for patients without events.

Secondary outcomes

  1. OS (Overall Survival)

    Time frame: 2 years

    Overall Survival (OS) was defined as the time interval from the date of diagnosis to the date of death or to last follow-up date.

  2. Molecular relapse (in ct DNA)

    Time frame: 2 years

    Molecular relapse was defined as the time interval from the date of any mutation negativization to the date of positive results of any mutation

Study contacts

Contact information is provided by the study sponsor or research team.

Katarzyna Maleszewska

CONTACT

[email protected]

+48 22 32 77 205

Sponsors and collaborators

Lead sponsor

Anna Raciborska

Other

Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology
  • Wroclaw University of Environmental and Life Sciences
  • Łukasiewicz Research Network

Registry information

Official study title

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

Acronym: HISTIOGEN

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2021
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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