99mTc-rhAnnexin V-128 Planar and SPECT Imaging of Apoptosis in Asymptomatic Or Previously Symptomatic With TIA Patients With Carotid Atherosclerotic Plaque
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Number of Participants Evaluated for Imaging Feasibility
研究概览
简要总结
This was a single-center, single-dose, study comprising a Proof of Concept (PoC) part and a subsequent Phase II part. The study was being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to image atherosclerotic plaque that might rupture and break off artery walls. This is caused by apoptosis or cell death in the plaque. These ruptured plaques can block blood circulation in the arteries causing a lack of oxygen to the tissues. Atherosclerotic plaques can build up on any artery in the body.
详细描述
The sponsor decided to terminate the study earlier than planned due to strategic decisions to focus the AAA development portfolio on oncology theragnostics and not based on safety concerns. Novartis acquired Advanced Accelerator Applications SA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all participants:
- •Males and females age 18 years or greater
- •Able and willing to comply with the study procedures
- •Negative pregnancy test for women of childbearing potential at screening and on the day of administration of 99mTc-rhAnnexin V-
- •For participants with carotid artery disease:
- •Evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years;
- •Evidence of 50% or more carotid stenosis in the most recent US imaging within 8 weeks prior to 99mTc-rhAnnexin V-128 administration
- •For control participants:
- •No significant carotid artery disease on carotid ultrasound;
- •No clinically significant abnormalities in baseline laboratory values.
排除标准
- •Previous carotid stending, endarterectomy or stroke;
- •Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans);
- •Pregnancy or lactation;
- •History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment;
- •Know hypersensitivity to the investigational product or any of its components;
- •Claustrophobia or inability to lie still in a supine position;
- •Participation in another clinical trial within 4 weeks before study inclusion, except for patients who have participated or who are currently participating in a study without any study drug administration;
- •Unwillingness to provide consent.
结局指标
主要结局
Number of Participants Evaluated for Imaging Feasibility
时间窗: Day 0
The frequency and severity of abnormal carotid scans was determined in the CAD participants and control groups by review of the number, localization, length and uptake intensity grade of each plaque to define a positive or negative scan at each time point. The feasibility of imaging apoptotic activity in CAD using 99mTc-rhAnnexin V-128 was assessed by the data monitoring committee (visual image review and consensus). The three reviewers of the DMC did an independent visual assessment of the images using a 1 to 4 point grading system: each observer reviewed the images of each patient and scored either 1 or 2 (uptake was less than or equal to blood pool), these images were considered normal; 3 was equivocal and four equalled abnormal. Only descriptive analysis performed.
Percentage of Participants With Prevalence of Abnormal 99mTc-rhAnnexin V-128 SPECT/CT Imaging (Phase II Step)
时间窗: At 60 and 120 minutes post injection on Day 0
The prevalence of apoptotic activity was defined as the percentage of participants with "abnormal" Single-Photon Emission Computed Tomography (SPECT) imaging scans (also described as positive scans). The overall result of 99mTc-rhAnnexin V-128 imaging was unique: participants with at least one SPECT imaging as positive result (after 60 min or after 120 min from 99mTc-rhAnnexin V-128 injection) were considered as abnormal, participants with SPECT/CT images as negative were considered as normal. All images were acquired with a dual head SPECT/CT gamma camera with low-energy high-resolution collimators. Only descriptive analysis performed.
次要结局
- Descending Aorta Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR)(At 60 and 120 minutes post injection on Day 0)
- Aortic Arch Uptake Correlation Imaging Assessment as Measured by Target to Background Ratio (TBR)(At 60 and 120 minutes post injection on Day 0)
- Left Carotid Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR)(At 60 and 120 minutes post injection on Day 0)
- Right Carotid Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR)(At 60 and 120 minutes post injection on Day 0)
- Ascending Aorta Uptake Imaging Assessment as Measured by Target to Background Ratio (TBR)(At 60 and 120 minutes post injection on Day 0)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and Death(From Day 0 post injection up to Day 30)
- Number of Participants With Clinically Significant Abnormal Laboratory Values(From Day 0 post injection up to Day 30)
- Left Carotid Uptake Imaging Assessment as Measure by Target to Background Ratio (TBR) by Ultrasound Grade of Plaque Echolucency/Echogenicity(At 60 and 120 minutes post injection on Day 0)
- Right Carotid Uptake Imaging Assessment as Measure by Target to Background Ratio (TBR) by Ultrasound Grade of Plaque Echolucency/Echogenicity(At 60 and 120 minutes post injection on Day 0)