Supra-Aortic StenosisCAPLNCT04466787
Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation
A study testing Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy CT (DECT) in people with Supra-Aortic Stenosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supra-Aortic Stenosis
- What is being tested?
- Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy CT (DECT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2019to 24 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Supra-Aortic Stenosis
- Being tested
- Spectral Photon Counting Computed Tomography (SPCCT), Dual Energy CT (DECT)
- Keywords
- diagnostic, carotid plaque, SPCCT
- Medical subject headings
- Aortic Stenosis, Supravalvular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral Photon Counting Computed Tomography (SPCCT)Diagnostic test
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.
Dual Energy CT (DECT)Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Spectral Photon Counting Computed Tomography (SPCCT) | Experimental | The randomized SPCCT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis Receives: Diagnostic Test: Spectral Photon Counting Computed Tomography (SPCCT) |
| Dual Energy CT (DECT) | Active comparator | The randomized DECT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis Receives: Diagnostic Test: Dual Energy CT (DECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Necrotic Core (LNC) in mm² identified with SPCCT
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Lipid Necrotic Core (LNC) in mm² identified with DECT
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Lipid Necrotic Core (LNC) in mm² identified with histology
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Intra Plaque Hemorrhage (IPH) in mm² identified with SPCCT
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Intra Plaque Hemorrhage (IPH) in mm² identified with DECT
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Intra Plaque Hemorrhage (IPH) identified with histology
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Fibrous Cap Ulceration (FCU) in mm² identified with SPCCT
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Fibrous Cap Ulceration (FCU) in mm² identified with DECT
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Fibrous Cap Ulceration (FCU) in mm² identified with histology
measurement of the height and thickness of surface of the plaque's components
Measured: 1 month
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 1 month
radiation dose received during SPCCT
Measured: 1 month
radiation dose received during DECT
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start20 Jun 2019
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supra-Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DOUEK, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466787
- Sponsor's protocol ID
- 69HCL18_0412
- Other IDs
- 2018-A02696-49
- Acronym
- CAPL
- Status last verified
- Jul 2024
- First submitted
- 19 Mar 2020
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04466787
- Acronym / sponsor ID
- CAPL / 69HCL18_0412
- Conditions
- Supra-Aortic Stenosis
- Keywords
- diagnostic, carotid plaque, SPCCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spectral Photon Counting Computed Tomography (SPCCT) | Experimental | Diagnostic Test: 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 |
| Dual Energy CT (DECT) | Active comparator | Diagnostic Test: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Spectral Photon Counting Computed Tomography (SPCCT) |
| 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 | Diagnostic test | Dual Energy CT (DECT) |
Primary outcome
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
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
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
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
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
Intra Plaque Hemorrhage (IPH) identified with histology
Time frame: 1 month
measurement of the height and thickness of surface of the plaque's components
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
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
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
12 secondary outcomes
Number of irregularities identified with SPCCT
Time frame: 1 month
Number of irregularities identified with DECT
Time frame: 1 month
Number of irregularities identified with MRI
Time frame: 1 month
Number of ulcerations identified with SPCCT
Time frame: 1 month
Number of ulcerations identified with DECT
Time frame: 1 month
Number of ulcerations identified with MRI
Time frame: 1 month
Assessable vascular segments with lack of image artifacts
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
Time frame: 1 month
Tolerance to DECT assessed by a tolerance survey
Time frame: 1 month
Tolerance to MRI assessed by a tolerance survey
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe DOUEK, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy CT (DECT) in people with Supra-Aortic Stenosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Necrotic Core (LNC) in mm² identified with SPCCT (time frame: 1 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.