2024-515636-77-00招募中2 期
An exploratory study of [18F]AlF-NOTA-octreotide PET/MRI in carotid artery disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The quantification of [18F]AlF-OC uptake in the culprit and non-culprit carotid artery by measures of standardized uptake value (SUV)
研究概览
简要总结
This single-center prospective study aims to evaluate the potential of [18F]AlF-OC PET/MRI in characterizing and quantifying carotid atherosclerotic disease in patients with recent stroke/TIA.
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
- 否
入选标准
- •Participant is aged over 18 years.
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure
- •CT angiography imaging at baseline should be available as part of routine care
- •Participant is diagnosed with a recent ischemic stroke or high-risk TIA (ABCD2 ≥ 4) in the carotid artery territory and ≥ 30% carotid artery stenosis. The stroke/TIA has occurred no more than 21 days prior to tracer administration.
排除标准
- •Female who is pregnant or breast-feeding.
- •Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification
- •Participant has a previous or ongoing recurrent or chronic disease at high risk to interfere with the performance or evaluation of the trial, according to the judgment of the investigator
- •Participants treated with carotid endarterectomy or carotid artery stenting within the past year
- •Subject has a contra-indication for or cannot tolerate MR scanning
- •Subject has an impaired renal function estimated glomerular filtration rate (eGFR) < 40 ml/min/1.73m² (the last known value may not date from more than 3 months prior to the study PET/MR; if not available a blood analysis may be performed as part of the trial)
- •Concurrent treatment with corticosteroids and/or somatostatin analogues
- •Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator
结局指标
主要结局
The quantification of [18F]AlF-OC uptake in the culprit and non-culprit carotid artery by measures of standardized uptake value (SUV)
The quantification of [18F]AlF-OC uptake in the culprit and non-culprit carotid artery by measures of standardized uptake value (SUV)
次要结局
- The predictive value of baseline plaque SUV for the recurrence of ipsilateral TIA, amaurosis fugax and stroke during 3 years follow-up, the recurrence of all stroke/TIA, the occurrence of any vascular complication (stroke/TIA, myocardial infarction, cardiac arrest, hospitalisation for unstable angina or vascular death) and the occurrence of all-cause mortality
研究者
Lemmens Robin
Scientific
UZ Leuven
研究点 (1)
Loading locations...
相似试验
招募中
2 期
[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery DiseaseNCT07104487Universitaire Ziekenhuizen KU Leuven24
尚未招募
2 期
The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer - FUTURE TrialBladder CancerNCT07257718Chiti Arturo262
招募中
1 期
Performance and prognostic value of 68Ga-FAPI PET/CT in non-small cell lung cancer (NSCLC)2023-503985-21-00Meander Medical Center20
已完成
1 期
Positron emission tomography using a newly-developed PET probe: [18F] Fluoroacetate (FACE) - human volunteer studyhealthy volunteerJPRN-UMIN000007575Shiga Medical Center Research Institute4
撤回
不适用
Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBMAstrocytoma, Grade IVGiant Cell GlioblastomaGlioblastoma MultiformeNCT00943462Centre hospitalier de l'Université de Montréal (CHUM)