Atherosclerotic plaque within the carotid artery. MedDRA version: 9.1 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease
Conditions
Interventions
Product Name: Sinerem
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Ferumoxtran-10 (USAN)
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.0
Sponsors
GlaxoSmithKline Research & Development, LtdD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 80 years of age inclusive. Women must be of nonchildbearing potential, defined as: • Pre-menopausal females with a documented tubal ligation or hysterectomy; • Postmenopausal defined as 12 months of spontaneous amenorrhea. 2. Atherosclerotic plaque within the carotid artery as assessed by carotid ultrasound either documented prior to screening or detected at the screening visit. 3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 4. Participants must read and write (in English) at a level sufficient to complete study related assessments. 5. Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is willing to take part in the imaging sessions. 6. Registered with a UK general practitioner 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: Parts A, B, C: 1. Pregnant females as determined by positive urine hCG test at screening and prior to each MRI scanning session. 2. Contraindication to MRI scanning including but not limited to: 3. Intracranial aneurysm clips (except Sugita) with an appropriate operative conformation, • History of intra- orbital metal fragments that have not been removed by an MD, • Pacemakers and non-MR compatible heart valves, • Inner ear implants, • History of claustrophobia. 4. History of any of the following medical conditions: • Myocardial Infarction or Cerebrovascular Accident within the past 2 weeks • Severe heart failure (NYHA class III-IV or ejection fraction 20mg (or equivalent) for four full weeks prior to screening. 4. Exclusion criteria relating to Sinerem infusion, including but not limited to: • A history of clinically significant atopy (e.g. anaphylaxis, skin rash to medication or topical therapies, hypersensitivity to iodinated contrasts, allergies to food (e.g. shellfish), bronchial asthma, etc.), • Allergy to dextran or iron salts • Haemachromatosis or other condition putting subject at risk of iron overload • Chronic severe back pain 5. Exclusion criteria relating to SonoVue, including but not limited to: • A history of known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue. • Evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders on ECG (as determined by the Principal Investigator). • A history of right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in subjects with adult respiratory distress syndrome. • A history of clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease. • A history of acute endocarditis, prostetic valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, and end-stage renal or hepatic disease. • Ventilated subjects, and those with unstable neurological diseases. 6. Chronic use of: • Immunosuppressants (cyclosporine, methotrexate, etc.). • Oral steroids therapy. • Clopidogrel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To develop Sinerem enhanced MRI data acquisition and analysis methods at 3T in order to characterize macrophage uptake in atherosclerotic plaques within the carotid artery.;Secondary Objective: • To determine the optimal Sinerem dose for use of MRI scanning of carotid atherosclerosis at 3T. • To evaluate the test-retest reproducibility of a specific set of structural and T2* related metrics in Part C (which we will develop in Parts A and B) over two scanning sessions in subjects with atherosclerosis. • To contribute safety data to the Guerbet Sinerem Global Safety Database.;Primary end point(s): An optimized Sinerem enhanced 3T MRI examination to characterize atherosclerotic plaque in the carotid artery. | — |
Countries
United Kingdom
Outcome results
None listed