Back to resultsComparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT) (SPEQUA)
Primary Purpose
Diabetic Foot Ulcer, Coronary Artery Disease, Parenchymatous; Pneumonia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spectral Photon Counting Computed Tomography (SPCCT)
DECT (Dual Energy CT)
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic Foot Ulcer focused on measuring Diagnostic, SPCCT
Eligibility Criteria
Inclusion Criteria:
Patients presenting following one of following medical conditions:
- Asymptomatic type 1 or 2 diabetes as regard to cardiovascular risks
- Diabetic foot ulcer
- Adrenal glands lesions: Adrenal incidentaloma or hyperaldosteronism or macroadenoma
- Urinary stone(s)
- Known Coronary artery disease: Stent imaging or control of calcified plaques
- Diffuse Interstitial Lung Diseases: Idiopathic Pulmonary Fibrosis, Hypersensitivity Pneumonitis, Ground Glass Opacification, Chronic Thromboembolic Pulmonary Hypertension
- Conductive hearing loss
- Brain stroke (late or post thrombectomy)
- Intracranial arteriovenous malformation treated with coils or Onyx
- Joints diseases in haemophilia
- Patient has accepted to participate to the study and has signed the written consent;
- Pre-menopausal women only: Negative urinary pregnancy test on the day of imaging before the administration of study drug;
- Patient is affiliated to the French social security
Exclusion Criteria:
- Contraindication to the use of iodine containing contrast media (including subjects with suspicion for/or known to have NSF) (if injection);
- 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);
- History of delayed major or delayed cutaneous reaction to Iomeron injection
- Estimated Glomerular Filtration Rate (eGFR) value < 30 mL/min/1.73 m2 derived from a serum creatinine result within 1 month before the imaging for examinations with contrast agent.
- Any subject on hemodialysis or peritoneal dialysis;
- Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery);
- Pregnant or nursing (including pumping for storage and feeding);
- Patient under guardianship, curatorship or safeguard of justice.
Sites / Locations
- Hôpital Cardiologique Louis Pradel - Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPCCT and standard DECT
Arm Description
Comparative intra-patients (each patient will have both types of scanner imaging done), clinical superiority study, evaluating the imaging performances (e.g. image quality and radiation dose) of SPCCT and standard DECT for several body regions/anatomical structures.
Outcomes
Primary Outcome Measures
quality of the images
A single four-point scale will be used (1: unacceptable, 2: usable under limited conditions, 3: probably acceptable, 4: fully acceptable) based on the European guidelines on quality criteria for computed tomography
Secondary Outcome Measures
Diagnostic confidence graded
The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good).
Subjective image quality graded
It will be calculated on a five-point scale (1: poor, 2: fair, 3: average, 4: good, 5: excellent) for each following criterion: noise, artifacts and sharpness.
CT Dose Index volumic (CTDIvol)
To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.
The CTDI is an estimation of the dose delivered to the organs for each acquired section that is based on acquisition parameters of a water phantom with a 32 cm diameter. The value is expressed in milligray (mGy).
Dose Length Product (DLP)
To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.
The DLP is obtained as follows: CTDI * length of body explored = value in mGy.cm.
Equivalent dose (mSv)
To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.
The equivalent dose is obtained by multiplying the DLP to the specific organ conversion factor.
Quantitatively image quality : Noise
The noise by selecting regions of interest (ROI) will calculated.
Quantitatively image quality : Density
The density (HU) by selecting regions of interest (ROI) will calculated.
Quantitatively image quality : contrast-to-noise ratio
The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.
Depiction of anatomical structures of interest
Depiction of anatomical structures of interest will be graded on a four-point scale (1: visualization just possible, 2: unclear borders but different structures already visible, 3: very good visualization, well-defined anatomy, 4: perfect delineation of anatomy).
Radiation dose
An average radiation dose delivered to the patients for each clinical application will be calculated.
Statistical comparison between SPCCT and DECT
Statistical comparison between SPCCT and DECT will be performed over all images and anatomical structures globally and also for each clinical application of interest.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04328181
Brief Title
Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
Acronym
SPEQUA
Official Title
Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
January 29, 2024 (Anticipated)
Study Completion Date
January 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study wants to determine to which extent SPCCT allows obtaining images with improved quality and diagnostic confidence when compared to standard Dual Energy CT (DECT), both with and without contrast agent injection.
Depending on the anatomical structures/organs to be visualized during CT examinations, different scanning protocols are performed with quite variable ionizing radiation doses. Therefore, in order to obtain the most extensive and representative results of the improvement in image quality between SPCCT and DECT that will be performed CT imaging on several body regions and structures, including diabetic foot, diabetic calcium coronary scoring, adrenal glands, coronary arteries, lung parenchyma, kidney stones, inner ear, brain and joints, earl/temporal bone, colorectal carcinosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Coronary Artery Disease, Parenchymatous; Pneumonia, Kidney Stone, Inner Ear Disease, Brain Stroke, Joint Diseases, Diabetes, Adrenal Incidentaloma, Hyperaldosteronism, Macroadenoma, Interstitial Lung Disease, Intracranial Arteriovenous Malformations
Keywords
Diagnostic, SPCCT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SPCCT and standard DECT
Arm Type
Experimental
Arm Description
Comparative intra-patients (each patient will have both types of scanner imaging done), clinical superiority study, evaluating the imaging performances (e.g. image quality and radiation dose) of SPCCT and standard DECT for several body regions/anatomical structures.
Intervention Type
Device
Intervention Name(s)
Spectral Photon Counting Computed Tomography (SPCCT)
Intervention Description
For the dual-layer spectral CT scanner (IQon®, Philips, Amsterdam, The Netherlands), the following parameters will be used for the acquisition:
Tube potential 120 kVp;
Tube current time product of 150 mAs;
Gantry revolution time 0.33 s;
Automatic exposure control (angular and longitudinal) combined xyz-axis;
Beam collimation geometry 64 x 0.625 mm - scan field-of-view - 22 cm;
Intervention Type
Device
Intervention Name(s)
DECT (Dual Energy CT)
Intervention Description
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 20 mm. It is equipped with energy-sensitive photon-counting detectors relying on the direct conversion high band gap semiconductor of cadmium zinc telluride (CZT). The electronics comprises 5 rate counters with 5 different configurable energy thresholds. The SPCCT scanner has the following parameters:
Base platform : iCT scanner
Tube Voltage (kVp) : 120, capability for imaging at 80 and 100 kVp
Tube current (mA) : 10 - 300
Spatial Resolution : > 30 lp/cm, ≤ 250 µm
Z-coverage isocenter (mm) : 20 mm
FOV (mm) : 500
Minimum rotation time : 0.33 s/rotation
Acquisition modes : Axial, Helical, Step & Shoot
Primary Outcome Measure Information:
Title
quality of the images
Description
A single four-point scale will be used (1: unacceptable, 2: usable under limited conditions, 3: probably acceptable, 4: fully acceptable) based on the European guidelines on quality criteria for computed tomography
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Diagnostic confidence graded
Description
The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good).
Time Frame
Day 8
Title
Subjective image quality graded
Description
It will be calculated on a five-point scale (1: poor, 2: fair, 3: average, 4: good, 5: excellent) for each following criterion: noise, artifacts and sharpness.
Time Frame
Day 8
Title
CT Dose Index volumic (CTDIvol)
Description
To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.
The CTDI is an estimation of the dose delivered to the organs for each acquired section that is based on acquisition parameters of a water phantom with a 32 cm diameter. The value is expressed in milligray (mGy).
Time Frame
Day 8
Title
Dose Length Product (DLP)
Description
To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.
The DLP is obtained as follows: CTDI * length of body explored = value in mGy.cm.
Time Frame
Day 8
Title
Equivalent dose (mSv)
Description
To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.
The equivalent dose is obtained by multiplying the DLP to the specific organ conversion factor.
Time Frame
Day 8
Title
Quantitatively image quality : Noise
Description
The noise by selecting regions of interest (ROI) will calculated.
Time Frame
Day 8
Title
Quantitatively image quality : Density
Description
The density (HU) by selecting regions of interest (ROI) will calculated.
Time Frame
Day 8
Title
Quantitatively image quality : contrast-to-noise ratio
Description
The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.
Time Frame
Day 8
Title
Depiction of anatomical structures of interest
Description
Depiction of anatomical structures of interest will be graded on a four-point scale (1: visualization just possible, 2: unclear borders but different structures already visible, 3: very good visualization, well-defined anatomy, 4: perfect delineation of anatomy).
Time Frame
Day 8
Title
Radiation dose
Description
An average radiation dose delivered to the patients for each clinical application will be calculated.
Time Frame
Day 8
Title
Statistical comparison between SPCCT and DECT
Description
Statistical comparison between SPCCT and DECT will be performed over all images and anatomical structures globally and also for each clinical application of interest.
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting following one of following medical conditions:
Asymptomatic type 1 or 2 diabetes as regard to cardiovascular risks
Diabetic foot ulcer
Adrenal glands lesions: Adrenal incidentaloma or hyperaldosteronism or macroadenoma
Urinary stone(s)
Known Coronary artery disease: Stent imaging or control of calcified plaques
Diffuse Interstitial Lung Diseases: Idiopathic Pulmonary Fibrosis, Hypersensitivity Pneumonitis, Ground Glass Opacification, Chronic Thromboembolic Pulmonary Hypertension
Conductive hearing loss
Brain stroke (late or post thrombectomy)
Intracranial arteriovenous malformation treated with coils or Onyx
Joints diseases in haemophilia
Ear/temporal bone
Colorectal carcinosis
Patient has accepted to participate to the study and has signed the written consent;
Pre-menopausal women only: Negative urinary pregnancy test on the day of imaging before the administration of study drug;
Patient is affiliated to the French social security
Exclusion Criteria:
Contraindication to the use of iodine containing contrast media (including subjects with suspicion for/or known to have NSF) (if injection);
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);
History of delayed major or delayed cutaneous reaction to Iomeron injection
Estimated Glomerular Filtration Rate (eGFR) value < 30 mL/min/1.73 m2 derived from a serum creatinine result within 1 month before the imaging for examinations with contrast agent.
Any subject on hemodialysis or peritoneal dialysis;
Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery);
Pregnant or nursing (including pumping for storage and feeding);
Patient under guardianship, curatorship or safeguard of justice.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe DOUEK, Pr
Phone
04 72 07 18 83
Ext
+33
Email
douek@creatis.insa-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Adeline MANSUY
Phone
04 72 11 51 70
Ext
+33
Email
adeline.mansuy@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DOUEK, Pr
Organizational Affiliation
Service de Radiologie, l'Hôpital Louis Pradel - Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon
City
Bron
State/Province
Avenue Doyen Lépine
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe DOUEK, Pr
Phone
04 72 35 73 53
Email
philippe.douek@chu-lyon.fr
12. IPD Sharing Statement
Learn more about this trial
Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
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