Clinical trial NCT04328181: Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
Official title: Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Keywords: Diagnostic
SPCCT
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: quality of the images
timeFrame: Day 8
Secondary outcomes:
measure: Diagnostic confidence graded
timeFrame: Day 8
measure: Subjective image quality graded
timeFrame: Day 8
measure: CT Dose Index volumic (CTDIvol)
timeFrame: Day 8
measure: Dose Length Product (DLP)
timeFrame: Day 8
measure: Equivalent dose (mSv)
timeFrame: Day 8
measure: Quantitatively image quality : Noise
timeFrame: Day 8
measure: Quantitatively image quality : Density
timeFrame: Day 8
measure: Quantitatively image quality : contrast-to-noise ratio
timeFrame: Day 8
measure: Depiction of anatomical structures of interest
timeFrame: Day 8
measure: Radiation dose
timeFrame: Day 8
measure: Statistical comparison between SPCCT and DECT
timeFrame: Day 8
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon
state: Avenue Doyen Lépine
Study officials:
affiliation: Service de Radiologie, l'Hôpital Louis Pradel - Hospices Civils de Lyon
name: Philippe DOUEK, Pr
role: PRINCIPAL_INVESTIGATOR
References: