SPEQUA: Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04328181

Collaborator

(none)

210

Enrollment

Location

Arm

17.9

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
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	Device: Spectral Photon Counting Computed Tomography (SPCCT) Device: DECT (Dual Energy CT)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)

Actual Study Start Date :

Jan 29, 2021

Anticipated Primary Completion Date :

Jul 29, 2022

Anticipated Study Completion Date :

Jul 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPCCT and standard DECT 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) 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; Device: DECT (Dual Energy CT) 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

Arm

Intervention/Treatment

Experimental: SPCCT and standard DECT

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)

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;

Device: DECT (Dual Energy CT)

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

Outcome Measures

Primary Outcome Measures

quality of the images [Day 8]
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 [Day 8]
The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good).
Subjective image quality graded [Day 8]
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) [Day 8]
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) [Day 8]
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) [Day 8]
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 [Day 8]
The noise by selecting regions of interest (ROI) will calculated.
Quantitatively image quality : Density [Day 8]
The density (HU) by selecting regions of interest (ROI) will calculated.
Quantitatively image quality : contrast-to-noise ratio [Day 8]
The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.
Depiction of anatomical structures of interest [Day 8]
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 [Day 8]
An average radiation dose delivered to the patients for each clinical application will be calculated.
Statistical comparison between SPCCT and DECT [Day 8]
Statistical comparison between SPCCT and DECT will be performed over all images and anatomical structures globally and also for each clinical application of interest.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.