RecruitingNCT05688592

Usefulness of PET-CT for Invasive Fungal Infection

A Prospective Multicenter Study to Determine the Usefulness of Systematic 18-FDG-PET-TC for the Management of Invasive Fungal Infection (PETIFI Project)


Sponsor

Puerta de Hierro University Hospital

Enrollment

224 participants

Start Date

Apr 27, 2023

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • -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.

Exclusion Criteria4

  • 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.

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Interventions

PROCEDUREPET-CT

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


Locations(14)

Hospital Universitario Puerta de Hierro

Majadahonda, Madriid, 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

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NCT05688592


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