Detection of venous thromboembolism
Conditions
Interventions
Product Name: EP-2104R
Product Code: EP-2104R
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: EP2104-30
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
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 diagnosis of thrombus by one of the following imaging studies: Cohort A (PE): • CT of the chest • V/Q scan • 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantitatively determine the imaging properties of EP-2104R for the characterisation of thrombus at different time points post-injection (e.g. signal intensity/enhancement, contrast to noise ratio, assessment of thrombus size).;Secondary Objective: - To determine the region-specific sensitivity compared to a reference standard generated by the institution's index diagnostic imaging data. - To qualitatively and quantitatively determine the imaging properties of EP-2104R for vascular imaging post-injection. - 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
Outcome results
None listed