Actively Recruiting

Age: 18Years +
All Genders
ID05688592

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

On this page

Sponsors

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

Outcome evaluations at 100 days and 6 months

Trial Site Locations

Total: 14 locations

1

Hospital Universitario Puerta de Hierro

Majadahonda, Madriid, Spain, 28222

Actively Recruiting

2

Hospital de Bellvitge

Barcelona, Spain

Actively Recruiting

3

Hospital Universitario Clinic

Barcelona, Spain

Actively Recruiting

4

Hospital Universitario Virgen de las Nieves

Granada, Spain

Actively Recruiting

5

Hospital Infanta Leonor Hospital

Madrid, Spain

Actively Recruiting

6

Hospital Universitario Gregorio Marañón

Madrid, Spain

Actively Recruiting

7

Hospital Universitario La Paz

Madrid, Spain

Actively Recruiting

8

Hospital Unversitario Ramón y Cajal

Madrid, Spain

Actively Recruiting

9

Hospital Virgen de la Victoria

Málaga, Spain

Actively Recruiting

10

Hospital Morales Messeguer

Murcia, Spain

Not Yet Recruiting

11

Hospital Virgen de la Arrixaca

Murcia, Spain

Not Yet Recruiting

12

Hospital Universitario Central de Asturias

Oviedo, Spain

Actively Recruiting

13

Hospital Unversitario de Salamanca

Salamanca, Spain

Actively Recruiting

14

Hospital Universitario Virgenn de la Macarena

Seville, Spain

Actively Recruiting

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Research Team

A

Andrea Gutiérrez Villanueva, MD

B

Begoña Rodríguez Alfonso, MDPhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/37355275