Assessing the effectiveness of PET-CT imaging in diagnosing histiocytosis in children
Determination of Molecular Status, as Well as the Efficacy and Safety of Fluorodeoxyglucose (18F-FDG) in PET-CT Imaging in Juvenile Patients With Histiocytosis
This study is testing if a special type of imaging called PET-CT can help doctors better diagnose histiocytosis in children.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Institute of Mother and Child, Warsaw, Poland Academic / other |
| Locations | 1 site (Warsaw, Mazovian) |
| Trial ID | NCT04943211 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve the diagnosis of histiocytosis in pediatric patients by evaluating the molecular profile of tumor tissues and free-circulating DNA. It involves a prospective, low-intervention approach where the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging will be assessed. The study is part of the POLHISTIO project, which focuses on understanding the mutations associated with histiocytosis and their clinical implications. Additionally, an immortalized cell line will be developed to explore the disease's pathogenesis and treatment responses.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 18 years of age with confirmed or suspected histiocytosis.
Not a fit: Patients who are pregnant or have other acute disorders that may complicate their participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnostics and better treatment strategies for children with histiocytosis.
How similar studies have performed: Other studies have shown promise in using molecular profiling and advanced imaging techniques for similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Warsaw, Mazovian
- Mother and Child Institute — Warsaw, Mazovian, Poland (Recruiting)
Study contacts
- Principal investigator: Anna Raciborska — Mother and Child Institute
- Study coordinator: Katarzyna Maleszewska
- Email: klinika.onkologii@imid.med.pl
- Phone: +48 22 32 77 205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.