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

Phase 3RecruitingNCT04943211

Anna Raciborska150 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Histiocytosis

Interventions

fluorodeoxyglucose (18F-FDG)DRUG

max 6 MGBq/kg, no more than 100

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mother and Child Institute

Warsaw, Mazovian, Poland

RECRUITING

Outcomes

Primary Outcomes

EFS - (event-free survival)

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.

Time frame: 2 years

Secondary Outcomes

OS (Overall Survival)

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.

Time frame: 2 years

Molecular relapse (in ct DNA)

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

Time frame: 2 years

Central Contacts

Katarzyna Maleszewska

CONTACT

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

Data from ClinicalTrials.gov

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