Phase II feasibility study to evaluate the safety and efficacy of EP-2104R for Magnetic Resonance Imaging of thrombi in the arterial vasculature and cardiac chambers

Epix Pharmaceuticals, Inc.0 个研究点目标入组 32 人开始时间: 2006年6月20日最近更新: 2012年3月19日

适应症

试验速览

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•- able to understand and provide written informed consent;
•- = 18 years of age;
•- have: a. a diagnosis of thrombus by an indexing exam; or
•b. have imaging evidence such as a complex plaque or stenosis of 80% or greater indicating a strong likelihood of thrombus in the carotid artery; or
•c. have imaging evidence such as a complex plaque greater than 4 mm thickness indicating a strong likelihood of thrombus in the aorta;
•- are clinically stable for at least 24 hours prior to first MR imaging session;
•- are a candidate for MR imaging within 48 hours of the indexing exam;
•- are able to undergo an MR scan for at least 30 minutes in the supine position;
•- have a negative pregnancy test at baseline if female of child-bearing potential; and
•- be clinically stable in the opinion of the investigator and have no other life-threatening illness or organ system dysfunction, which would either intervene with their safety or interfere with the evaluation of EP-2104R.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- women who are pregnant or lactating;
•- if there has been any major therapeutic intervention (i.e. lysing agent, thrombectomy) between the initial positive indexing exam and EP-2104R administration;
•- if there is a specific magnetic resonance exclusion criteria including but not limited to contraindications such as a pacemaker, ear implants, internal defibrillator, internal infusion pumps, ferromagnetic intracranial aneurysm clips, any site-specific MR exclusion, or severe claustrophobia;
•- if they are on mechanical ventilation or are otherwise not considered clinically stable;
•- if they have received any investigational drug or device within 30 days prior to EP-2104R administration; and
•- if there is a known hypersensitivity to any contrast agent.

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