Usefulness of PET-CT for Invasive Fungal Infection
ConditionInvasive Fungal Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPuerta de Hierro University Hospital
About this trial
The goal of this national multicenter prospective cohort study is to learn about the added value of 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose) PET-CT in invasive fungal disease management. The main questions it aims to answer are:
1. Does the use of 18F-FDG PET-CT allow a better characterization of invasive fungal infection (IFI) (performance) compared to the exclusive use of conventional radiological studies in terms of extension/staging and monitoring of response/follow-up ? 2. Does the systematic and protocolized use of 18F-FDG PET-CT in IFI allow a better management of patients with IFI and increase the prognostic value of the initial evaluation? Participants will undergo systematically a 18F-FDG PET-CT as part of the work-up of their invasive fungal disease. Researchers will compare the performance of 18F-FDG PET-CT with standard management without 18F-FDG PET-CT to see if adds value (diagnostic, prognostic, and changes in management).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-year-old adult patients
who are admitted with a diagnosis of invasive fungal infection
who able to undergo a one 18F-FDG PET-CT
who give their informed consent.
Disqualifiers
concomitant active bacterial infection likely to produce uptake in organs and tissues
recent surgery in the area of the IFI (in the previous 3 months)
other medical conditions that interfere with the development of the study ( e.g., inability to tolerate the performance of the test during the required time, pregnancy)
terminal situation.
Trial population
Adult patients admitted with a diagnosis of invasive fungal infection, both fungemia or focal fungal infection
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
PET-CT
Procedure/SurgeryThis is a before-and-after study (not a clinical trial) * in the case of fungemia, 2 weeks after the initial staging 18F-FDG PET-CT. * in the case of focal IFIs, 2-4 and 12 weeks after the initial staging 18F-FDG PET-CT
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Duration of antifungal treatment
Length of anti fungal therapy
Time frame
6 months2
Survival
Alive at the last visit
Time frame
6 monthsSecondary outcomes
1
Resumption of chemotherapy or performance of stem cell transplantation
The infection recedes enough to allow the receipt of chemotherapy
Time frame
6 months2
Recurrence of invasive fungal infection
New episode of fungal infection caused by the same pathogen
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Puerta de Hierro University Hospital
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov