Application of Radiomics in Molecular Imaging (18F-FDG-PET/CT) for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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)
干预措施: PET/CT imaging (Radiation)
结局指标
主要结局
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.
时间窗: 1 month and 12 months
Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.
次要结局
- To evaluate the role of radiomics in monitoring suppressive antimicrobial therapy in patients with retained infected devices.(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.(1 month and 12 month)