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

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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04943211

Acronym

HISTIOGEN

Enrollment

150

Registered

2021-06-29

Start date

2021-04-01

Completion date

2027-06-30

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histiocytosis

Keywords

Langerhans cell histiocytosis (LCH), histiocytosis, Positron Emission Tomography (PET), molecular status, paediatric patients

Brief 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.

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

Interventions

DRUGfluorodeoxyglucose (18F-FDG)

max 6 MGBq/kg, no more than 100

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
EFS - (event-free survival)	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

Measure	Time frame	Description
OS (Overall Survival)	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.
Molecular relapse (in ct DNA)	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

Countries

Poland

Contacts

CONTACTKatarzyna Maleszewska

klinika.onkologii@imid.med.pl+48 22 32 77 205

PRINCIPAL_INVESTIGATORAnna Raciborska

Mother and Child Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026