A Prospective Multicenter Study to Determine the Usefulness of Systematic 18-FDG-PET-TC for the Management of Invasive Fungal Infection (PETIFI Project)
Led by Puerta de Hierro University Hospital · Updated on 2024-11-06
224
Participants Needed
14
Research Sites
4 weeks
Total Duration
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P
Puerta de Hierro University Hospital
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the value of using 18F-FDG PET-CT scans in managing invasive fungal infections (IFIs). This national multicenter prospective cohort study across 14 Spanish hospitals aims to see if PET-CT provides better detection and monitoring of IFIs compared to conventional imaging. The study focuses on improving diagnosis, staging, treatment monitoring, and prognosis for patients with fungemia or focal IFI.
Participants will receive a systematic 18F-FDG PET-CT scan as part of their IFI evaluation. For fungemia patients, a follow-up PET-CT is done 2 weeks after the initial scan. For those with focal IFIs, additional scans occur at 2-4 weeks and 12 weeks after the first PET-CT. The scans help assess infection spread and response to treatment. The study collects comprehensive clinical, microbiological, and imaging data, comparing PET-CT results with standard care imaging.
Patients will be monitored through medical history reviews, clinical tests, and imaging evaluations. Specialists will interpret PET-CT images locally and centrally to standardize findings. The team will assess how PET-CT influences disease staging, treatment decisions, and outcomes. Key measures include antifungal treatment duration and survival at 6 months. Patient progress is evaluated at 100 days and 6 months, including infection recurrence and continuation of cancer treatments if applicable.
CONDITIONS
Brief Title
Usefulness of PET-CT for Invasive Fungal Infection
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Adult patients aged 18 years or older
Admitted with a diagnosis of invasive fungal infection
Able to undergo one 18F-FDG PET-CT scan
Provided informed consent to participate
You will not qualify if you...
Active bacterial infection that could cause uptake in organs and tissues
Recent surgery in the area of the invasive fungal infection within the last 3 months
Medical conditions interfering with study participation (e.g., inability to tolerate the test, pregnancy)
Terminal condition
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within 1 week after diagnosis
Participants undergo an initial 18F-FDG PET-CT scan within the first week after diagnosis to stage the invasive fungal infection.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 12 weeks after initial PET-CT
Participants are monitored with follow-up 18F-FDG PET-CT scans to assess response to treatment and disease progression.
For fungemia: 1 visit at 2 weeks; for focal invasive fungal infections: visits at 2-4 weeks and 12 weeks
Surveillance
Duration - 6 months
Participants' outcomes including treatment duration, recurrence, and survival are evaluated up to 6 months after diagnosis.
Determining the usefulness of systematic 18F-FDG PET/CT for the management of invasive fungal infection (PETIFI project): a prospective national multicentre cohort study protocol.
Andrea Gutiérrez, Begoña Rodriguez, Karina Velasquez...