CompletedNCT04466787CAPLUpdated Jul 15, 2024

Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation

An interventional study of Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy CT (DECT) in Supra-Aortic Stenosis, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic

From the registry’s dates

Registered 8 months after the study started (first participant enrolled Jun 2019, registered Mar 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 22
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

In this study, the investigator propose to determine the efficiency of a new and more sophisticated imaging prototype, the Spectral Photon Counting Computed Tomography (SPCCT), at characterizing vulnerable plaques and luminal stenosis in Carotid Atherosclerosis patients compared to DECT (Dual Energy CT) and MRI (Magnetic Resonance Imaging) which are used in current practice

Conditions studied

Supra-Aortic Stenosis

Browse trials for

Aortic Valve Stenosis 985

Keywords

diagnostic
carotid plaque
SPCCT

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 22 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female subjects of any ethnic background, aged > 18 years
Any of the following known or suspected supra-aortic arterial disease based on : Prior stroke; Transient Ischemic Attack; Amaurosis Fugax; Referred for evaluation of any supra-aortic vessel; Follow-up for a stent in a supra-aortic vessel; Prior imaging ultrasounds study showing > ou = 50 % stenosis of a supra-aortic vessel segment (within 60 days before consent)
Patient undergoing surgery within one month of carotid plaque evaluation
Willingness and ability to follow directions and complete all study procedures specified in the protocol
Pre-menopausal women only : Negative urinary pregnancy test on the day of imaging before the administration of study drug
Patient has accepted to participate to the study and has signed the written consent
Patient is affiliated to social security

Exclusion criteria

Exclusion Criteria:

Contraindication to MRI examinations (e.g. inability to hold breath, severe arrhythmias, very low cardiac output, severe claustrophobia, metallic devices not approved for MRI such as defibrillators, pacemaker, heart valve prostheses, cochlear implants, neuro-stimulators, implanted automated injection device, intraocular metallic foreign bodies, neurosurgical and vascular clips);
Contraindication to the use of iodine and gadolinium containing contrast media (including subjects with suspicion for/or known to have NSF);- History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents (as judged by the investigator, taking into account the intensity of the event);
Estimated Glomerular Filtration Rate (eGFR) value \< 30 mL/min/1.73 m2 derived from a serum creatinine result within 1 month before the imaging;
Any subject on hemodialysis or peritoneal dialysis (Note: If there are multiple creatinine values, the values obtained prior to and closest to the time of the examination should be used);
Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the per-operative liver transplantation period;
Known subject history of severe cardiovascular disease (e.g. acute myocardial infarction [\< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome;
Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery);
Scheduled or potentially expected for the period between the SPCCT or DECT and MRI: Any procedure that may alter the MRI or CT interpretation; Any interventional or surgical procedure involving the supra-aortic vessels.
Pregnant or nursing (including pumping for storage and feeding); 11. Patient under guardianship, curators or safeguard of justice.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 22 participants (actual)

Study arms

Experimental
Spectral Photon Counting Computed Tomography (SPCCT)
The randomized SPCCT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis
Diagnostic Test: Spectral Photon Counting Computed Tomography (SPCCT)
Active comparator
Dual Energy CT (DECT)
The randomized DECT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis
Diagnostic Test: Dual Energy CT (DECT)

Interventions

Diagnostic testSpectral Photon Counting Computed Tomography (SPCCT)
The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients \< 80 kg and 1 mL/kg for patients \> 80 kg, with a maximum of 90 mL. The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field of View (FOV) of 168 mm in-plane, and a z-coverage of 2 mm.
Diagnostic testDual Energy CT (DECT)
The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients \< 80 kg and 1 mL/kg for patients \> 80 kg, with a maximum of 90 mL. DECT : IQon, Philips

What researchers measure

Primary outcomes

Lipid Necrotic Core (LNC) in mm² identified with SPCCT
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month
Lipid Necrotic Core (LNC) in mm² identified with DECT
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month
Lipid Necrotic Core (LNC) in mm² identified with histology
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month
Intra Plaque Hemorrhage (IPH) in mm² identified with SPCCT
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month
Intra Plaque Hemorrhage (IPH) in mm² identified with DECT
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month
Intra Plaque Hemorrhage (IPH) identified with histology
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month
Fibrous Cap Ulceration (FCU) in mm² identified with SPCCT
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month
Fibrous Cap Ulceration (FCU) in mm² identified with DECT
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month
Fibrous Cap Ulceration (FCU) in mm² identified with histology
measurement of the height and thickness of surface of the plaque's components
Time frame: 1 month

Secondary outcomes

Number of irregularities identified with SPCCT
- Irregularities as defined by \< 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
Time frame: 1 month
Number of irregularities identified with DECT
- Irregularities as defined by \< 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
Time frame: 1 month
Number of irregularities identified with MRI
- Irregularities as defined by \< 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
Time frame: 1 month
Number of ulcerations identified with SPCCT
- Ulceration as defined by \> 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
Time frame: 1 month
Number of ulcerations identified with DECT
- Ulceration as defined by \> 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
Time frame: 1 month
Number of ulcerations identified with MRI
- Ulceration as defined by \> 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
Time frame: 1 month
Assessable vascular segments with lack of image artifacts
It will be assessed by estimating the image quality on scale from 1 to 4 (1 = poor, 2 = moderate, 3 = good, and 4 = excellent)
Time frame: 1 month
radiation dose received during SPCCT
Time frame: 1 month
radiation dose received during DECT
Time frame: 1 month
Tolerance to SPCCT assessed by a tolerance survey
1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004
Time frame: 1 month
Tolerance to DECT assessed by a tolerance survey
1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004
Time frame: 1 month
Tolerance to MRI assessed by a tolerance survey
1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004
Time frame: 1 month

Study locations

1 site

Louis Pradel cardiovascular Hospital
Bron, France

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04466787
Lead sponsor: Hospices Civils de Lyon
Responsible party: Sponsor
First posted: Jul 10, 2020
Start date: Jun 20, 2019
Primary completion: Nov 24, 2021
Completion: Nov 24, 2021
Last update: Jul 15, 2024

Study contacts

Philippe DOUEK, Pr

principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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