Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT04763603 |
Other study ID # |
D18-P007 |
Secondary ID |
|
Status |
Terminated |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 29, 2019 |
Est. completion date |
March 17, 2020 |
Study information
Verified date |
February 2021 |
Source |
Centre Hospitalier St Anne |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Identification of intraplaque haemorrhage using MRI is technically demanding and sometimes
uncomfortable. Photoacoustic imaging is a new non-invasive technique combining
multi-wavelength infrared laser light and ultrasound imaging, able to discriminate blood and
other components in the tissues. The measurement by the multi-spectral photoacoustic imaging
is likely to be more acceptable and therefore could replace MRI.
Description:
A total of 60 patients with stenosis grade of > 70% and considered for endarterectomy will be
recruited for additional imaging. Pre-operative PA/US and 3D MR imaging will be conducted.
Two patient groups are designed to allow performance assessment with respect to anatomy,
i.e., penetration depth; One with favourable anatomy (i.e. superficial carotids, proximal
plaques and low bifurcation), the other with no anatomical considerations. For in-vivo
verification of the morphology and mechanical properties obtained with PA/US imaging, the
pre-operative data will be compared to the MR data (imaging-imaging verification). Since the
patient is operated on, endarterectomy specimens are available for histo-pathological
examination and in-vitro testing for verification purposes: the excised tissue will be (snap
freeze with liquid Nitrogen) transported to TUE in Eindhoven for in-vitro validation
(imaging-histology verification). Paris patients will undergo surgery and tissues will be
transferred to Eindhoven for in vitro mechanical testing. Because of the transfer (-80 °C),
the rate of success for in vitro testing is expected to be smaller, around 40% (i.e. 12
subjects). Nevertheless, the power of the global analysis will be increased.