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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2019-A02945-52 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPCCT and standard DECT | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectral Photon Counting Computed Tomography (SPCCT) | Device | For the dual-layer spectral CT scanner (IQon®, Philips, Amsterdam, The Netherlands), the following parameters will be used for the acquisition:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic confidence graded | The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good). | 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. |
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Inclusion Criteria:
Patients presenting following one of following medical conditions:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe DOUEK, Pr | Contact | 04 72 07 18 83 | +33 | douek@creatis.insa-lyon.fr |
| Adeline MANSUY | Contact | 04 72 11 51 70 | +33 | adeline.mansuy@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe DOUEK, Pr | Service de Radiologie, l'Hôpital Louis Pradel - Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon | Recruiting | Bron | Avenue Doyen Lépine | 69500 | France |
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| DECT (Dual Energy CT) | Device | 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:
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| 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). | 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. | 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. | Day 8 |
| Quantitatively image quality : Noise | The noise by selecting regions of interest (ROI) will calculated. | Day 8 |
| Quantitatively image quality : Density | The density (HU) by selecting regions of interest (ROI) will calculated. | Day 8 |
| Quantitatively image quality : contrast-to-noise ratio | The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated. | 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). | Day 8 |
| Radiation dose | An average radiation dose delivered to the patients for each clinical application will be calculated. | 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. | Day 8 |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003324 | Coronary Artery Disease |
| D011014 | Pneumonia |
| D007669 | Kidney Calculi |
| D007759 | Labyrinth Diseases |
| D007592 | Joint Diseases |
| D003920 | Diabetes Mellitus |
| C538238 | Adrenal incidentaloma |
| D006929 | Hyperaldosteronism |
| D017563 | Lung Diseases, Interstitial |
| D002538 | Intracranial Arteriovenous Malformations |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009140 | Musculoskeletal Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
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