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

Phase 3

Recruiting

• Conditions: Histiocytosis
• Interventions: Drug: fluorodeoxyglucose (18F-FDG)

• Registration Number: NCT04943211
• Lead Sponsor: Anna Raciborska

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

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R1 low intervention arm	fluorodeoxyglucose (18F-FDG)	Children of both sexes who meet all inclusion criteria and do not meet any exclusion criteria will be eligible for the study.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mother and Child Institute; 🇵🇱 Warsaw, Mazovian, Poland