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

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ClinicalTrials.gov Identifier: NCT04466787
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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

Condition or disease Intervention/treatment Phase
Supra-Aortic Stenosis Diagnostic Test: Spectral Photon Counting Computed Tomography (SPCCT) Diagnostic Test: Dual Energy CT (DECT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The images will be read without knowing the CT scan used
Primary Purpose: Diagnostic
Official Title: Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation.
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
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)

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.


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)

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





Primary Outcome Measures :
  1. Lipid Necrotic Core (LNC) in mm² identified with SPCCT [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components

  2. Lipid Necrotic Core (LNC) in mm² identified with DECT [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components

  3. Lipid Necrotic Core (LNC) in mm² identified with histology [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components

  4. Intra Plaque Hemorrhage (IPH) in mm² identified with SPCCT [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components

  5. Intra Plaque Hemorrhage (IPH) in mm² identified with DECT [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components

  6. Intra Plaque Hemorrhage (IPH) identified with histology [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components

  7. Fibrous Cap Ulceration (FCU) in mm² identified with SPCCT [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components

  8. Fibrous Cap Ulceration (FCU) in mm² identified with DECT [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components

  9. Fibrous Cap Ulceration (FCU) in mm² identified with histology [ Time Frame: 1 month ]
    measurement of the height and thickness of surface of the plaque's components


Secondary Outcome Measures :
  1. Number of irregularities identified with SPCCT [ Time Frame: 1 month ]
    - 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.

  2. Number of irregularities identified with DECT [ Time Frame: 1 month ]
    - 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.

  3. Number of irregularities identified with MRI [ Time Frame: 1 month ]
    - 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.

  4. Number of ulcerations identified with SPCCT [ Time Frame: 1 month ]
    - 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.

  5. Number of ulcerations identified with DECT [ Time Frame: 1 month ]
    - 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.

  6. Number of ulcerations identified with MRI [ Time Frame: 1 month ]
    - 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.

  7. Assessable vascular segments with lack of image artifacts [ Time Frame: 1 month ]
    It will be assessed by estimating the image quality on scale from 1 to 4 (1 = poor, 2 = moderate, 3 = good, and 4 = excellent)

  8. radiation dose received during SPCCT [ Time Frame: 1 month ]
  9. radiation dose received during DECT [ Time Frame: 1 month ]
  10. Tolerance to SPCCT assessed by a tolerance survey [ Time Frame: 1 month ]
    1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004

  11. Tolerance to DECT assessed by a tolerance survey [ Time Frame: 1 month ]
    1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004

  12. Tolerance to MRI assessed by a tolerance survey [ Time Frame: 1 month ]
    1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466787


Contacts
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Contact: Philippe DOUEK, Pr 4 72 07 18 83 ext +33 douek@creatis.insa-lyon.fr
Contact: Adeline MANSUY 4 72 11 51 70 ext +33 adeline.mansuy@chu-lyon.fr

Locations
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France
Louis Pradel cardiovascular Hospital Recruiting
Bron, France
Contact: Douek Philippe, Pr       douek@creatis.insa-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Philippe DOUEK, Pr Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04466787    
Other Study ID Numbers: 69HCL18_0412
2018-A02696-49 ( Other Identifier: IDRCB )
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
diagnostic
carotid plaque
SPCCT
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Stenosis, Supravalvular
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction