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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04490343
Other study ID # PI2020_843_0053
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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