Carotid atherosclerosis MedDRA version: 9.1 Level: LLT Classification code 10003601 Term: Atherosclerosis
Conditions
Interventions
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to beginning study-related procedures (subject must understand the aims, investigational procedures and possible consequences of the study). 2. Male or female aged 18 or older at screening. 3. Demonstrable Carotid atherosclerosis on screening ultrasound 4. Active arm: About to initiate chemotherapy with anti-angiogenic activity (including bevicizumab, axitinib, sorafenib, sunitinib, cetuximab, pazopanib, imatinib, MK646-004, and panitumimab) 5. Control arm: About to initiate chemotherapy with no anti angiogenic activity 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: • Hypersensitivty to sulphur hexaflouride or any other components of sonovue • Recent acute coronary syndrome (within 2 weeks) • Clinically unstable ischaemic disease • Right to left shunt • Severe pulmonary hypertension • Uncontrolled systemic hypertension • Women who are pregnant or lactacting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether carotid plaque neovascularisation, as defined by contrast enhanced ultrasound (CEUS), is reduced following chemotherapy with anti-angiogenic activity.;Secondary Objective: No secondary objectives;Primary end point(s): • Changes from baseline in relative vascular volume, as defined by CEUS derived Carotid Plaque peak intensity / Carotid artery peak intensity, at 12 weeks following initiation of chemotherapy (within groups’ comparison). | — |
Countries
United Kingdom
Outcome results
None listed