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

August 19, 2026 updated by: Anna Raciborska

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Mazovian
      • Warsaw, Mazovian, Poland, 01-211
        • Recruiting
        • Mother and Child Institute
        • Contact:
        • Principal Investigator:
          • Anna Raciborska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Lack of inclusion criteria.
  2. Pregnancy.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: R1 low intervention arm
Children of both sexes who meet all inclusion criteria and do not meet any exclusion criteria will be eligible for the study.
Drug: fluorodeoxyglucose (18F-FDG)
max 6 MGBq/kg, no more than 100
Other Names:
  • GLUNEKTIK; SYNEKTIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years
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 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Raciborska

Collaborators

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

Investigators

  • Principal Investigator: Anna Raciborska, Mother and Child Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HISTIOGEN.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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