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
- Conditions
- Detection of thrombi in the arterial vasculature and cardiac chambers
- Registration Number
- EUCTR2004-004701-23-CZ
- Lead Sponsor
- Epix Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method