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Clinical Trials/NCT04490343
NCT04490343
Active, not recruiting
Not Applicable

Detection of Urinary Tract Stones on Ultra-low Dose Abdominopelvic CT Imaging With Deep-learning Image Reconstruction Algorithm

Centre Hospitalier Universitaire, Amiens1 site in 1 country62 target enrollmentJuly 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urolithiasis
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
62
Locations
1
Primary Endpoint
Accuracy between low dose CT using DLIR reconstruction and low dose CT without DLIR reconstruction for the detection of urinary tract stones
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

Urolithiasis has an increasing incidence and prevalence worldwide, and some patients may have multiple recurrences. Because these stone-related episodes may lead to multiple diagnostic examinations requiring ionizing radiation, urolithiasis is a natural target for dose reduction efforts. Abdominopelvic low dose CT, which has the highest sensitivity and specificity among available imaging modalities, is the most appropriate diagnostic exam for this pathology. The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in urolithiasis patients.

Registry
clinicaltrials.gov
Start Date
July 21, 2020
End Date
July 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old,
  • Patient referred for abdominopelvic CT to confirm urolithiasis or for follow-up,
  • Affiliation to a social security program,
  • Ability of the subject to understand and express opposition

Exclusion Criteria

  • Age \<18 years old,
  • Person under guardianship or curators,
  • Pregnant woman,
  • Any contraindications to CT

Outcomes

Primary Outcomes

Accuracy between low dose CT using DLIR reconstruction and low dose CT without DLIR reconstruction for the detection of urinary tract stones

Time Frame: day 1

Accuracy between low dose CT using DLIR reconstruction and low dose CT without DLIR reconstruction for the detection of urinary tract stones. Patients who were referred to the department for abdominopelvic CT exam for urolithiasis diagnostic or follow-up, and had consented to participate in the study, will undergo an additional ultra-low dose acquisition (ULD, \<1 mSv) with deep learning-based reconstruction (DLIR).

Study Sites (1)

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