Status:

RECRUITING

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

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

Diabetic Foot Ulcer

Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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
  • 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

Exclusion

  • 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.

Key Trial Info

Start Date :

January 29 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 29 2026

Estimated Enrollment :

339 Patients enrolled

Trial Details

Trial ID

NCT04328181

Start Date

January 29 2021

End Date

January 29 2026

Last Update

April 4 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hôpital Cardiologique Louis Pradel - Hospices Civils de Lyon

Bron, Avenue Doyen Lépine, France, 69500