A 12 week observational study to evaluate the effects of the initiation of chemotherapy with anti-angiogenic activity on neovascularisation (as determined by contrast enhanced ultrasound, (CEUS)) within coincidental asymptomatic carotid atherosclerotic plaques. - Effect of chemotherapy on atherosclerotic plaque neovascularisatio

Conditions: Carotid atherosclerosis
MedDRA version: 9.1Level: LLTClassification code 10003601Term: Atherosclerosis

Registration Number: EUCTR2008-005924-97-GB

Lead Sponsor: Imperial College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 26

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

•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures