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

NCT04490343 | Unknown

• 1 other identifier: PI2020_843_0053
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Urinary Tract Stones; Renal Colic; Deep Learning Reconstruction

Keywords

Urolithiasis; Urinary Tract Stones; Renal Colic; deep learning reconstruction; radiation dose; dose reduction; low dose CT

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Abdominopelvic low dose CT DIAGNOSTIC_TEST

Patients with urinary stones will undergo multiple computed tomography (CT) examinations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Urolithiasis; Urinary Calculi; Renal Colic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: July 21, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)