Usefulness of PET-CT for Invasive Fungal Infection
PETIFI
A Prospective Multicenter Study to Determine the Usefulness of Systematic 18-FDG-PET-TC for the Management of Invasive Fungal Infection (PETIFI Project)
1 other identifier
observational
224
1 country
14
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedStudy Start
First participant enrolled
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 6, 2024
November 1, 2024
1.5 years
December 20, 2022
November 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration of antifungal treatment
Length of anti fungal therapy
6 months
Survival
Alive at the last visit
6 months
Secondary Outcomes (2)
Resumption of chemotherapy or performance of stem cell transplantation
6 months
Recurrence of invasive fungal infection
6 months
Interventions
This 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
Eligibility Criteria
Adult patients admitted with a diagnosis of invasive fungal infection, both fungemia or focal fungal infection
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Puerta de Hierro University Hospitallead
- Gilead Sciencescollaborator
Study Sites (14)
Hospital Universitario Puerta de Hierro
Majadahonda, Madriid, 28222, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital Universitario Clinic
Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Infanta Leonor Hospital
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Unversitario Ramón y Cajal
Madrid, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Morales Messeguer
Murcia, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Unversitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgenn de la Macarena
Seville, Spain
Related Publications (1)
Gutierrez A, Rodriguez B, Velasquez K, Gutierrez I, Garcia S, Munez E, Calderon-Parra J, Callejas-Diaz A, Ramos-Martinez A, Fernandez-Cruz A. 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. BMJ Open. 2023 Jun 23;13(6):e074240. doi: 10.1136/bmjopen-2023-074240.
PMID: 37355275DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Fernández Cruz, MDPhD
Hospital Puerta de Hierro-Majadahonda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 20, 2022
First Posted
January 18, 2023
Study Start
April 27, 2023
Primary Completion
October 31, 2024
Study Completion
December 1, 2024
Last Updated
November 6, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Starting 6 months after publication
- Access Criteria
- The Individual Patient Data underlying results in a publication will be shared
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.