Phase II Feasibility study of safety and efficacy of Magnetic Resonance Imaging of Thrombi with EP-2104R in the detection in Venous Thromboembolism (VTE)

Epix Pharmaceuticals, Inc.0 个研究点目标入组 16 人开始时间: 2005年2月10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 diagnosis of thrombus by one of the following imaging studies:
•Cohort A (PE):
•CT of the chest
•Pulmonary angiography (XRA, CTA, MRA)
•Cohort B (DVT):
•CT angiography
•Ultrasound
•Venography
•If appropriate, another diagnostic imaging exam not listed above may be
•considered upon doscussion with the sponsor
•- clinically stable for at least 24 hours prior to first MR imaging session
•- are a candidate for MR imaging within 48 hours of the index imaging exam
•- able to undergo an MR scan for at least 30 minutes in the supine position
•- have a negative pregnancy test at baseline
•- be clinically stable and in the opinion of the Investigator, have no other lifethreatening illness or organ system dysfunction, which would either intervene with the patient’s 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
•- Any major therapeutic intervention (i.e. lysing agent, thrombectomy) between the initial positive imaging study and EP-2104R administration
•- 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
•- Patients who are on mechanical ventilation, or are otherwise not considered clinically stable
•- Patients with receipt of any investigational drug or device within 30 days prior to EP-2104R administration
•- Patients with a known hypersensitivity to any contrast agent

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