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NCT03656913 Clinical Trial

Validation of Low Dose CT for Diagnosis of Urolithiasis

Nephrolithiasis Clinical Trial

Official title:
Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Urolithiasis in Children and Young Adults

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03656913
Other study ID # 2018-5183
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 30, 2018
Est. completion date September 28, 2020

Study information
Verified date February 2021
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 15
Est. completion date September 28, 2020
Est. primary completion date September 28, 2020
Accepts healthy volunteers No
Gender All
Age group 4 Years to 20 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Extremely low dose CT
Patients undergoing clinically indicated CT will also receive the extremely low dose CT

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Burnet Campus Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic performance of extremely low dose CT Sensitivity Immediate
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