RecruitingPhase 3NCT04943211

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


Sponsor

Anna Raciborska

Enrollment

150 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study improves the diagnosis and treatment of histiocytosis — a rare group of diseases caused by abnormal growth of immune cells — in patients under 18 years old by analyzing genetic mutations in tumor tissue and blood. Researchers will also evaluate whether a PET-CT scan using a radioactive sugar (fluorodeoxyglucose) can accurately detect disease activity in these patients. Children under 18 with a confirmed or suspected histiocytosis diagnosis are eligible, provided they or their guardians can provide informed consent. Participation involves genetic testing from tissue or blood samples and imaging with PET-CT scans as part of the diagnostic process. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGfluorodeoxyglucose (18F-FDG)

max 6 MGBq/kg, no more than 100


Locations(1)

Mother and Child Institute

Warsaw, Mazovian, Poland

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NCT04943211


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