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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04328181
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hospices Civils de Lyon
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Philippe DOUEK, Pr
Principal Investigator Affiliation	Service de Radiologie, l'Hôpital Louis Pradel - Hospices Civils de Lyon
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Arms & Interventions

Arms

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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bron, Avenue Doyen Lépine, France

Status

Recruiting

Address

Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon

Bron, Avenue Doyen Lépine, 69500

Site Contact

Philippe DOUEK, Pr

[email protected]

04 72 35 73 53

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