Determination of Molecular Status, as Well as the Efficacy and Safety of Fluorodeoxyglucose (18F-FDG) in PET-CT Imaging in Juvenile Patients With Histiocytosis

• Status: Recruiting
• Trial end date: 2026-06-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anna Raciborska
• Collaborators: Łukasiewicz Research Network; Maria Sklodowska-Curie Institute - Oncology Center; Wrocław University of Environmental and Life Sciences
• Treatments: Fluorodeoxyglucose F18

Criteria

Inclusion Criteria:

1. Patient under 18 years of age at the time of inclusion.

2. Histopatologically 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.