Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging
ConditionHistiocytosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-18
SponsorAnna Raciborska
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient under 18 years of age at the time of inclusion.
Histopathologically confirmed or suspected histiocytosis (based on prior test results).
Signing of informed consent for trial participation according with current legal regulations.
Disqualifiers
Lack of inclusion criteria.
Pregnancy.
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.
Trial design
Design model
Single group
Treatments tested in this trial
fluorodeoxyglucose (18F-FDG)
Drugmax 6 MGBq/kg, no more than 100
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: R1 low intervention armOther 1 intervention
Trial outcomes
Primary outcomes
1
EFS - (event-free survival)
Event-free survival (EFS) was defined as the time interval from the date of diagnosis to the date of disease progression, recurrence, second malignancy, death or to date of last follow-up for patients without events.
Time frame
2 yearsSecondary outcomes
1
OS (Overall Survival)
Overall Survival (OS) was defined as the time interval from the date of diagnosis to the date of death or to last follow-up date.
Time frame
2 years2
Molecular relapse (in ct DNA)
Molecular relapse was defined as the time interval from the date of any mutation negativization to the date of positive results of any mutation
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anna Raciborska
Lead sponsor
Institute of Mother and Child, Warsaw, Poland
Sponsor institution
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborator
Łukasiewicz Research Network
Collaborator
Wroclaw University of Environmental and Life Sciences
Collaborator
Source ClinicalTrials.gov