Clinical trial NCT04763603: Assessment of Plaque Vulnerability Using a Novel Technique: Multi-spectral PhotoAcoustic Imaging.
Official title: Assessment of Plaque Vulnerability Using a Novel Technique: Multi-spectral PhotoAcoustic Imaging.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neurology
Keywords: carotid stenosis
Photoacoustic imaging
Laser diode
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The project involves patients with atherosclerotic plaques (either symptomatic or not).

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.

Eligibility criteria: Inclusion Criteria:

* Presence of at least one carotid plaque with a degree of stenosis 70% (NASCET), indication to surgery (endarterectomy),
* Patients with favourable anatomy criteria :

x Cranio-caudal length of normal or long neck x Cervical adiposity weak or absent x Carotid bifurcation in usual situation (at the level of the mandibular angle or lower) x Normal genicity of subcutaneous tissues x Calcification of arterial moderate or absent

* Patients affiliated to the social health security system.

Exclusion Criteria:

* Refusal to participate,
* any concomitant chronic condition hampering the realization of ultrasound scanner or MRI (allergy to gel, intolerance or contraindication to gadolinium).
* Unstable patients with plaque claudication inducing procedure acceleration.
* Patients with unfavourable anatomy criteria :

x Cranio-caudal length of the neck very short x Significant cervical adiposity x Carotid bifurcation higher than the mandibular angle x High echogenic subcutaneous tissue x Calcification marked arterialH2020-ICT-29-2016 no. 731771 Ethics requirements x Patients with fat necks, Presence of extensive calcifications at the site of the stenosis.

* Patients unable to consent.
* Pregnant woman or breastfeeding woman

Primary outcomes:
measure: Evaluation of the device
timeFrame: 18 month
Secondary outcomes:
measure: Evaluation of anatomical concordance
timeFrame: 18 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Sainte-Anne Hospital
state: Ile De France
Study officials:
References: