Examination of the molecular profile in adolescent patients with histiocytic cell hyperplasia, and if a specific mutation is detected, its monitoring. Determination clinical benefit of use fludeoxyglucose (18F-FDG) in PET/CT imagining in with histiocytosis

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005051-20-PL

Enrollment

150

Registered

2021-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

histiocytic cell proliferation MedDRA version: 21.1 Level: PT Classification code 10069698 Term: Langerhans' cell histiocytosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10078782 Term: Langerhans cell sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10060801 Term: Erdheim-Chester

Interventions

Trade Name: GLUNEKTIK Product Name: GLUNEKTIK Pharmaceutical Form: Solution for infusion INN or Proposed INN: FLUDEOXYGLUCOSE (18F) CAS Number: 105851-17-0 Current Sponsor code: fluorodeoksyglukoza Ot

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 150 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of molecular status and benefit and safety of use fludeoxyglucose (18-FDG) in PET/CT imagening in juvenile patients with histiocytosis. ;Secondary Objective: 1. Evaluation of clinical benefit and safety of use fludeoxyglucose (18F-FDG) in PET/CT imagening in juvenile patients with histiocytosis. 2. To determine the frequency of BRAF mutation in juvenile patients in Poland. 3. To determine the frequency of other mutations in juvenile patients in Poland. 4. To determine the rate of occurrence of mutations in ctDNA at different parts of treatment and follow-up. 5. To evaluate the diagnostic usefulness of the occurrence of mutations in ctDNA as a prognostic factor compared with other recognized factors. 6. Establishing of an immortalized cell line.;Primary end point(s): EFS – (event-free survival). ;Timepoint(s) of evaluation of this end point: Interim analyzes were planned after the enrollment of 50 patients.	—

Measure

Time frame

Main Objective: Determination of molecular status and benefit and safety of use fludeoxyglucose (18-FDG) in PET/CT imagening in juvenile patients with histiocytosis. ;Secondary Objective: 1. Evaluation of clinical benefit and safety of use fludeoxyglucose (18F-FDG) in PET/CT imagening in juvenile patients with histiocytosis. 2. To determine the frequency of BRAF mutation in juvenile patients in Poland. 3. To determine the frequency of other mutations in juvenile patients in Poland. 4. To determine the rate of occurrence of mutations in ctDNA at different parts of treatment and follow-up. 5. To evaluate the diagnostic usefulness of the occurrence of mutations in ctDNA as a prognostic factor compared with other recognized factors. 6. Establishing of an immortalized cell line.;Primary end point(s): EFS – (event-free survival). ;Timepoint(s) of evaluation of this end point: Interim analyzes were planned after the enrollment of 50 patients.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: • PFS (Progression-Free Survival), • OS (Overall Survival), • ORR (Overall Response Rate), • Reactivation rate after 2 years, • Molecular relapse, • Time to negative mutation test results (in ctDNA), • Cell line measurements. Endpoints related to safety: • Rate of participants presenting with Adverse Events separated by degree of intensity, category, affected organ or system.;Timepoint(s) of evaluation of this end point: Interim analyzes were planned after the enrollment of 50 patients.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: • PFS (Progression-Free Survival), • OS (Overall Survival), • ORR (Overall Response Rate), • Reactivation rate after 2 years, • Molecular relapse, • Time to negative mutation test results (in ctDNA), • Cell line measurements. Endpoints related to safety: • Rate of participants presenting with Adverse Events separated by degree of intensity, category, affected organ or system.;Timepoint(s) of evaluation of this end point: Interim analyzes were planned after the enrollment of 50 patients.

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Countries

Poland

Contacts

Public ContactDepartment of Oncology and Surgical

Institute of Mother and Child

klinika.onkologii@imid.med.pl482232 77 205

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026