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

NCT ID: NCT04328181

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2026-01-29

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Spectral Photon Counting Computed Tomography (SPCCT)

Intervention Type: DEVICE

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)

Intervention Type: 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:

• 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

Interventions

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;

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe DOUEK, Pr

Role: PRINCIPAL_INVESTIGATOR

Service de Radiologie, l'Hôpital Louis Pradel - Hospices Civils de Lyon

Locations

Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon

Bron, Avenue Doyen Lépine, France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe DOUEK, Pr

Role: CONTACT

douek@creatis.insa-lyon.fr

04 72 07 18 83 ext. +33

Adeline MANSUY

Role: CONTACT

adeline.mansuy@chu-lyon.fr

04 72 11 51 70 ext. +33

Facility Contacts

Philippe DOUEK, Pr

Role: primary

philippe.douek@chu-lyon.fr

04 72 35 73 53

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0486

Identifier Type: -

Identifier Source: org_study_id