Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-07 @ 7:39 AM
Study NCT ID:
NCT04763603
Status:
TERMINATED
Last Update Posted:
2021-02-21
First Post:
2021-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Plaque Vulnerability Using a Novel Technique: Multi-spectral PhotoAcoustic Imaging.
Sponsor:
Centre Hospitalier St Anne
Organization:
Study Overview
Official Title:
Assessment of Plaque Vulnerability Using a Novel Technique: Multi-spectral PhotoAcoustic Imaging.
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
SARS-CoV-2 coronavirus outbreak and end of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
(CVENT-PAI)
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: