Detection of thrombi in the arterial vasculature and cardiac chambers
Conditions
Interventions
Product Name: EP-2104R
Product Code: EP2104-R
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: EP-2104-30
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Epix Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantitatively determine the imaging properties of EP-2104R for characterization of the thrombus at different time points post-injection (e.g. signal intensity/enhancement, contrast to noise ratio, assessment of thrombus size). ;Secondary Objective: Secondary study objectives include to determine region-specific sensitivity compared to a reference standard generated by a study institution’s index diagnostic imaging data; to qualitatively and quanitatively determine the imaging properties of EP-2104R for vascular imaging post-injection; and to determine the preliminary safety of EP-2104R.;Primary end point(s): - The signal intensity of the thrombus region as a function of time relative to drug injection; - The signal intensity of the blood as a function of time relative to drug injection; - The signal intensity of background tissue proximal to the thrombus region as a function of time relative to drug injection; - The mean and standard deviation of signal intensity of a uniform region of lung or air outside the body as a function of time relative to drug injection, as an estimate of the noise level. | — |
Countries
Czech Republic, Germany
Outcome results
None listed