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

NCT04328181 | Recruiting

• 2 other identifiers: 69HCL19_0486ID-RCB
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

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

Keywords

Diagnostic; SPCCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Diagnostic confidence graded

  Day 8

• Subjective image quality graded

  Day 8

• CT Dose Index volumic (CTDIvol)

  Day 8

• Dose Length Product (DLP)

  Day 8

• Equivalent dose (mSv)

  Day 8

Study Arms (1)

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.

Device: Spectral Photon Counting Computed Tomography (SPCCT); Device: DECT (Dual Energy CT)

Interventions

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: * 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;

SPCCT and standard DECT

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: * 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

SPCCT and standard DECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ear/temporal bone
• Colorectal carcinosis
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon

Bron, Avenue Doyen Lépine, 69500, France

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Coronary Artery Disease; Pneumonia; Kidney Calculi; Labyrinth Diseases; Joint Diseases; Diabetes Mellitus; Adrenal incidentaloma; Hyperaldosteronism; Lung Diseases, Interstitial; Intracranial Arteriovenous Malformations; Disease

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ear Diseases; Otorhinolaryngologic Diseases; Musculoskeletal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes

Study Officials

• Philippe DOUEK, Pr

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe DOUEK, Pr

CONTACT

04 72 07 18 83; douek@creatis.insa-lyon.fr

Adeline MANSUY

CONTACT

04 72 11 51 70; adeline.mansuy@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: January 29, 2021
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

FR (1)