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

Inclusion Criteria5

  • Patient under 18 years of age at the time of inclusion.
  • Histopathologically confirmed or suspected histiocytosis (based on prior test results).
  • Signing of informed consent for trial participation according with current legal regulations.
  • Pregnancy.
  • 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.

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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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