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

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer; Diabetes; Joint Diseases; Adrenal Incidentaloma; Hyperaldosteronism; Coronary Artery Disease; Parenchymatous; Pneumonia; Inner Ear Disease; Brain Stroke; Kidney Stone
• Interventions: Device: Spectral Photon Counting Computed Tomography (SPCCT); Device: DECT (Dual Energy CT)

• Registration Number: NCT04328181
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-03-31
• Study Start: 2021-01-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2026-01-29
• Study Completion: 2026-01-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 339

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPCCT and standard DECT	Spectral Photon Counting Computed Tomography (SPCCT)	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.
SPCCT and standard DECT	DECT (Dual Energy CT)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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).
Quantitatively image quality : Noise	Day 8	The noise 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.
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).
Radiation dose	Day 8	An average radiation dose delivered to the patients for each clinical application will be calculated.
Quantitatively image quality : Density	Day 8	The density (HU) 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).
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.

Trial Locations

Locations (1)

Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon; 🇫🇷 Bron, Avenue Doyen Lépine, France