Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging
Recruiting
Phase 3
Interventional Study
Histiocytosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 150 (estimated)
- Sponsor
- Anna Raciborska · Other
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About This Trial
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.
Trial Locations
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Eligibility 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…
Contacts