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

Coronary Artery Disease Clinical Trial

— SPEQUA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328181
• Other study ID #: 69HCL19_0486
• Secondary ID: ID-RCB
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: January 29, 2026

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Philippe DOUEK, Pr
• Phone: 04 72 07 18 83
• Email: douek[@]creatis.insa-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 339
• Est. completion date: January 29, 2026
• Est. primary completion date: January 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting following one of following medical conditions:

1. Asymptomatic type 1 or 2 diabetes as regard to cardiovascular risks

2. Diabetic foot ulcer

3. Adrenal glands lesions: Adrenal incidentaloma or hyperaldosteronism or macroadenoma

4. Urinary stone(s)

5. Known Coronary artery disease: Stent imaging or control of calcified plaques

6. Diffuse Interstitial Lung Diseases: Idiopathic Pulmonary Fibrosis, Hypersensitivity Pneumonitis, Ground Glass Opacification, Chronic Thromboembolic Pulmonary Hypertension

7. Conductive hearing loss

8. Brain stroke (late or post thrombectomy)

9. Intracranial arteriovenous malformation treated with coils or Onyx

10. Joints diseases in haemophilia

11. Ear/temporal bone

12. Colorectal carcinosis

13. Dissection aortique de type A opérée ou de type B non opérée, hématome intramural

• 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.

Related Conditions & MeSH terms

• Adrenal Incidentaloma
• Adrenocortical Adenoma
• Arteriovenous Malformations
• Brain Stroke
• Coronary Artery Disease
• Diabetes
• Diabetic Foot
• Diabetic Foot Ulcer
• Ear Diseases
• Foot Ulcer
• Hyperaldosteronism
• Inner Ear Disease
• Interstitial Lung Disease
• Intracranial Arteriovenous Malformations
• Joint Diseases
• Kidney Calculi
• Kidney Stone
• Labyrinth Diseases
• Labyrinthitis
• Lung Diseases
• Lung Diseases, Interstitial
• Macroadenoma
• Parenchymatous; Pneumonia

Intervention

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;
• 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

Locations

Country	Name	City	State
France	Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon	Bron	Avenue Doyen Lépine

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Day 8
Secondary	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
Secondary	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
Secondary	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
Secondary	Quantitatively image quality : Noise	The noise by selecting regions of interest (ROI) will calculated.	Day 8
Secondary	Quantitatively image quality : Density	The density (HU) by selecting regions of interest (ROI) will calculated.	Day 8
Secondary	Quantitatively image quality : contrast-to-noise ratio	The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.	Day 8
Secondary	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
Secondary	Radiation dose	An average radiation dose delivered to the patients for each clinical application will be calculated.	Day 8
Secondary	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