An interventional study of Spectral Photon Counting Computed Tomography (SPCCT) and DECT (Dual Energy CT) in Diabetic Foot Ulcer, Coronary Artery Disease and Parenchymatous; Pneumonia, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 339 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients presenting following one of following medical conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Spectral Photon Counting Computed Tomography (SPCCT) · Device: DECT (Dual Energy CT)
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;
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
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
Time frame: Day 8
Diagnostic confidence graded
The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good).
Time frame: Day 8
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.
Time frame: Day 8
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).
Time frame: Day 8
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.
Time frame: Day 8
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.
Time frame: Day 8
Quantitatively image quality : Noise
The noise by selecting regions of interest (ROI) will calculated.
Time frame: Day 8
Quantitatively image quality : Density
The density (HU) by selecting regions of interest (ROI) will calculated.
Time frame: Day 8
Quantitatively image quality : contrast-to-noise ratio
The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.
Time frame: Day 8
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).
Time frame: Day 8
Radiation dose
An average radiation dose delivered to the patients for each clinical application will be calculated.
Time frame: Day 8
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.
Time frame: Day 8
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