Validation of Low Dose CT for Diagnosis of Urolithiasis

Not Applicable

Terminated

• Conditions: Ureterolithiases; Nephrolithiasis
• Interventions: Diagnostic Test: Extremely low dose CT

• Registration Number: NCT03656913
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

The investigators have developed an extremely low dose renal computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. The investigators plan to test this exam in patients with known or suspected urolithiasis undergoing clinically indicated CT.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-04
• Study Start: 2018-11-30
• Primary Completion: 2020-09-28
• Study Completion: 2020-09-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Pediatric and young adult patients (ages 4 to <21 years)
• Known or suspected urolithiasis
• Undergoing clinically indicated CT of the abdomen/pelvis

Exclusion Criteria

• Pregnancy
• Prior enrollment in the same study (no patient will be enrolled more than once)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Extremely low dose CT	Patients will receive both the clinically indicated and extremely low dose CT exams

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of extremely low dose CT	Immediate	Sensitivity

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center Burnet Campus; 🇺🇸 Cincinnati, Ohio, United States