Detection of Urinary Stones on ULDCT With Deep-learning Image Reconstruction Algorithm

Urolithiasis Clinical Trial

— URO DLIR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04490343
• Other study ID #: PI2020_843_0053
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Deep Learning Reconstruction
• Renal Colic
• Urinary Calculi
• Urinary Tract Stones
• Urolithiasis

Intervention

Diagnostic Test:
• Abdominopelvic low dose CT
Patients with urinary stones will undergo multiple computed tomography (CT) examinations

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy between low dose CT using DLIR reconstruction and low dose CT without DLIR reconstruction for the detection of urinary tract stones	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).	day 1