2025-524624-21-00招募中4 期
Application of radiomics in molecular imaging (18F-FDG-PET/CT) for diagnosis and follow-up of cardiovascular device infections: PREDICT study
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.
研究概览
简要总结
To assess the diagnostic performance of radiomics applied to FDG-PET in patients with CVDIs, in comparison with standard visual and semiquantitative analysis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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).
- •FDG-PET studies that fail to meet the required quality standards.
研究组 & 干预措施
Fludesoxiglucosa (18F)-Curium 185 MBq/ml, solución inyectable
Test
干预措施: Fludesoxiglucosa (18F)-Curium 185 MBq/ml, solución inyectable (Drug)
结局指标
主要结局
Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.
Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.
次要结局
- Performance of AI-based predictive models (combining radiomic and clinical features) for: o Distinguishing infection vs. non-infection. o Predicting resolution of infection and supporting discontinuation of suppressive antimicrobial therapy.
- Characterization of physiological 18F-FDG uptake patterns in cardiovascular device carriers without infection, stratified by sex and time since implantation.
研究者
Dra. Marta Hernández-Meneses
Scientific
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
研究点 (1)
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