NCT04943211 Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging
| NCT ID | NCT04943211 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Anna Raciborska |
| Condition | Histiocytosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2021-04-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Anna Raciborska
PRINCIPAL INVESTIGATOR
Mother and Child Institute
Frequently Asked Questions
Who can join the NCT04943211 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Histiocytosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04943211 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT04943211 currently recruiting?
Yes, NCT04943211 is actively recruiting participants. Contact the research team at klinika.onkologii@imid.med.pl for enrollment information.
Where is the NCT04943211 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT04943211 clinical trial?
NCT04943211 is sponsored by Anna Raciborska. The principal investigator is Anna Raciborska at Mother and Child Institute. The trial plans to enroll 150 participants.