Diabetic Foot UlcerSPEQUANCT04328181
Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
A study testing Spectral Photon Counting Computed Tomography (SPCCT) and DECT (Dual Energy CT) in people with Diabetic Foot Ulcer and Coronary Artery Disease, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Coronary Artery Disease, Parenchymatous; Pneumonia
- What is being tested?
- Spectral Photon Counting Computed Tomography (SPCCT) and DECT (Dual Energy CT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2021to 29 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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;
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon
Bron, Avenue Doyen Lépine, 69500
Philippe DOUEK, Pr, 04 72 35 73 53, philippe.douek@chu-lyon.fr
About this study
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
- Being tested
- Spectral Photon Counting Computed Tomography (SPCCT), DECT (Dual Energy CT)
- Keywords
- Diagnostic, SPCCT
- Medical subject headings
- Diabetic Foot, Coronary Artery Disease, Pneumonia, Kidney Calculi, Labyrinth Diseases, Joint Diseases, Diabetes Mellitus, Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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;
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spectral Photon Counting Computed Tomography (SPCCT); Device: DECT (Dual Energy CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 8
Secondary outcomes (11)
Diagnostic confidence graded
The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good).
Measured: Day 8
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.
Measured: Day 8
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).
Measured: Day 8
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.
Measured: Day 8
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.
Measured: Day 8
Quantitatively image quality : Noise
The noise by selecting regions of interest (ROI) will calculated.
Measured: Day 8
Quantitatively image quality : Density
The density (HU) by selecting regions of interest (ROI) will calculated.
Measured: Day 8
Quantitatively image quality : contrast-to-noise ratio
The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.
Measured: Day 8
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).
Measured: Day 8
Radiation dose
An average radiation dose delivered to the patients for each clinical application will be calculated.
Measured: Day 8
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.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start29 Jan 2021
- Primary completion29 Jan 2026 (estimated)
- Study completion29 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DOUEK, Pr, Principal investigator, Service de Radiologie, l'Hôpital Louis Pradel - Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328181
- Sponsor's protocol ID
- 69HCL19_0486
- Other IDs
- ID-RCB
- Acronym
- SPEQUA
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2020
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
- ClinicalTrials.gov ID
- NCT04328181
- Acronym / sponsor ID
- SPEQUA / 69HCL19_0486
- Conditions
- Diabetic Foot Ulcer, Coronary Artery Disease, Parenchymatous; Pneumonia, Kidney Stone, Inner Ear Disease, Brain Stroke
- Keywords
- Diagnostic, SPCCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 29 Jan 2026 (estimated)
- Study completion
- 29 Jan 2026 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPCCT and standard DECT | Experimental | Device: Spectral Photon Counting Computed Tomography (SPCCT), Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients presenting following one of following medical conditions:
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | SPCCT and standard DECT |
| 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 | Device | SPCCT and standard DECT |
Primary outcome
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
11 secondary outcomes
Diagnostic confidence graded
Time frame: Day 8
Subjective image quality graded
Time frame: Day 8
CT Dose Index volumic (CTDIvol)
Time frame: Day 8
Dose Length Product (DLP)
Time frame: Day 8
Equivalent dose (mSv)
Time frame: Day 8
Quantitatively image quality : Noise
Time frame: Day 8
Quantitatively image quality : Density
Time frame: Day 8
Quantitatively image quality : contrast-to-noise ratio
Time frame: Day 8
Depiction of anatomical structures of interest
Time frame: Day 8
Radiation dose
Time frame: Day 8
Statistical comparison between SPCCT and DECT
Time frame: Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe DOUEK, Pr principal investigator
Service de Radiologie, l'Hôpital Louis Pradel - Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectral Photon Counting Computed Tomography (SPCCT) and DECT (Dual Energy CT) in people with Diabetic Foot Ulcer and Coronary Artery Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe DOUEK, Pr (04 72 07 18 83 ext. +33, douek@creatis.insa-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of the images (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.