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

April 3, 2024 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

339

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Avenue Doyen Lépine
      • Bron, Avenue Doyen Lépine, France, 69500
        • Recruiting
        • Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of the images
Time Frame: 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
Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic confidence graded
Time Frame: Day 8
The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good).
Day 8
Subjective image quality graded
Time Frame: 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.
Day 8
CT Dose Index volumic (CTDIvol)
Time Frame: 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).
Day 8
Dose Length Product (DLP)
Time Frame: 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.
Day 8
Equivalent dose (mSv)
Time Frame: 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.
Day 8
Quantitatively image quality : Noise
Time Frame: Day 8
The noise by selecting regions of interest (ROI) will calculated.
Day 8
Quantitatively image quality : Density
Time Frame: Day 8
The density (HU) by selecting regions of interest (ROI) will calculated.
Day 8
Quantitatively image quality : contrast-to-noise ratio
Time Frame: Day 8
The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.
Day 8
Depiction of anatomical structures of interest
Time Frame: 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).
Day 8
Radiation dose
Time Frame: Day 8
An average radiation dose delivered to the patients for each clinical application will be calculated.
Day 8
Statistical comparison between SPCCT and DECT
Time Frame: 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.
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Philippe DOUEK, Pr, Service de Radiologie, l'Hôpital Louis Pradel - Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Estimated)

January 29, 2026

Study Completion (Estimated)

January 29, 2026

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0486
  • ID-RCB (Other Identifier: 2023-A01937-38)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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