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Determination Of Molecular Status And Benefit Of Use Fludeoxyglucose (18F-FDG) In PET/CT imagining In Juvenile Patients With Histiocytosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515895-11-00
Acronym
HISTIOGEN
Enrollment
150
Registered
2024-08-26
Start date
2021-04-15
Completion date
Unknown
Last updated
2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

histiocytic cell proliferation

Brief summary

EFS – (event-free survival).

Detailed description

PFS (Progression-Free Survival), OS (Overall Survival), ORR (Overall Response Rate), Reactivation rate after 2 years, Rate of participants presenting with Adverse Events separated by degree of intensity, category, affected organ or system.

Interventions

DRUGFludeoxyglucose (18F) Synektik
DRUG200-2200 MBq/ml
DRUGGLUNEKTIK
DRUG1 GBq/mL

Sponsors

Instytut Matki I Dziecka
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
EFS – (event-free survival).

Secondary

MeasureTime frame
PFS (Progression-Free Survival), OS (Overall Survival), ORR (Overall Response Rate), Reactivation rate after 2 years, Rate of participants presenting with Adverse Events separated by degree of intensity, category, affected organ or system.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026