Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study

Официальное название

Application of Radiomics in Molecular Imaging (18F-FDG-PET/CT) for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study

Обзор

Single center, open-label, phase IV clinical trial to study the application of radiomics in molecular imaging for diagnosis and follow-up of CVDIs. The study will include three populations: * Retrospective cohort (2018-2025) * Prospective cohort (2026-2027) * Control group (prospective)

Подробное описание

The study is a single center, open-label, phase IV clinical trial to study the application of radiomics in molecular imaging for diagnosis and follow-up of CVDIs.

The study will be conducted in one Spanish hospital where two hundred patients will be included in the corresponding cohort according to their characteristics (see section "5.1 Description of Study Population"). The study will include three populations:

• Retrospective cohort (2018-2025): patients with a confirmed CVDIs who underwent FDG-PET for diagnosis or follow-up. The retrospective cohort will include patients from 2018 to 2025 who have already undergone FDG-PET imaging and for whom complete clinical, microbiological, and therapeutic data are available.

These data were collected under a previously approved protocol with CEIm (Clinical Research Ethics Committee) authorization: HCB/2015/0769 and HCB/2024/1173.

No new procedures will be performed on retrospective patients; only a re-analysis of existing FDG-PET/CT scans using radiomics techniques will be conducted.

• Prospective cohort (2026-2027): This cohort will include patients with a confirmed CVDI undergoing FDG-PET/CT as part of standard clinical care. Patients will be included before performing any FDG-PET/CT examination, which will be acquired after signing informed consent.

All diagnostic and therapeutic procedures, including antibiotic or SAT when indicated, will follow standard clinical practice and will not be influenced by the study.

Written informed consent will be obtained to authorize the use of their clinical and imaging data for research purposes.

• Control group (prospective): This group will include 40 patients with recently implanted cardiovascular devices and no clinical suspicion of infection, distributed as follows:

* 10 pacemakers, * 10 valvular prostheses, * 10 vascular prostheses, * 10 transcatheter aortic valve implants (TAVIs) Inclusion will occur after device implantation and informed consent signature. FDG-PET/CT imaging will be performed at approximately 1 month and 12 months post-implantation.

Вмешательства

• Лучевая терапия PET/CT imaging
  Inclusion will occur after device implantation and informed consent signature. FDG-PET/CT imaging will be performed at approximately 1 month and 12 months post-implantation. These patients will not receive any specific treatment related to the study, beyond the procedures planned in the study schedule to record potential adverse events related to FDG administration and to facilitate the communication of imaging results. All medical management will otherwise follow standard clinical practice.

Первичные конечные точки

• To assess the diagnostic performance of radiomics applied to FDG-PET in patients with cardiovascular device infections (CVDIs), in comparison with standard visual and semiquantitative analysis. [Срок оценки: 1 month and 12 months]

Вторичные конечные точки (2)

• To evaluate the role of radiomics in monitoring suppressive antimicrobial therapy in patients with retained infected devices. [Срок оценки: 1 month and 12 months]
• To identify normal 18F-FDG uptake patterns in cardiovascular devices in patients without suspected infection, stratified by sex and time from device implantation. [Срок оценки: 1 month and 12 month]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Implanted cardiovascular device (prosthetic valve, TAVI, CIED, vascular graft/endograft).
• For infected cohorts: patients studied by FDG-PET with definitive diagnosis of CVDI based on multidisciplinary evaluation.
• For control group: no clinical suspicion of infection at time of inclusion.
• Written Informed consent provided (prospective cohort and control group).
• Women of child-bearing potential must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence (only if refraining from heterosexual intercourse during the period of twelve months of duration of the study).

Критерии исключения

• Inability to undergo FDG-PET due to contraindications (e.g., allergies, claustrophobia).
• Pregnancy or breastfeeding.
• Incomplete clinical data or lack of access to imaging studies.
• Refusal or withdrawal of informed consent (for control and prospective cohort).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Испания · 1 центр

• Hospital Clinic Barcelona — Barcelona

Идентификаторы

NCT: NCT07454096 · 2025-524624-21-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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