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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Coronary Artery Disease; Joint Diseases; Kidney Stone; Macroadenoma; Inner Ear Disease; Diabetic Foot Ulcer; Interstitial Lung Disease; Brain Stroke; Diabetes; Hyperaldosteronism; Parenchymatous; Pneumonia; Intracranial Arteriovenous Malformations; Adrenal Incidentaloma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04328181

69HCL19_0486

ID-RCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 339 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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339 participants in 1 patient group

SPCCT and standard DECT

Experimental group

Description:

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.

Treatment:

Device: Spectral Photon Counting Computed Tomography (SPCCT)

Device: DECT (Dual Energy CT)