Validation of Low Dose CT for Diagnosis of Urolithiasis
Primary Purpose
Nephrolithiasis, Ureterolithiases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extremely low dose CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Nephrolithiasis focused on measuring Kidney Stone, Renal, Renal Stone
Eligibility Criteria
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)
Sites / Locations
- Cincinnati Children's Hospital Medical Center Burnet Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Patients will receive both the clinically indicated and extremely low dose CT exams
Outcomes
Primary Outcome Measures
Diagnostic performance of extremely low dose CT
Sensitivity
Secondary Outcome Measures
Full Information
NCT ID
NCT03656913
First Posted
August 31, 2018
Last Updated
February 17, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03656913
Brief Title
Validation of Low Dose CT for Diagnosis of Urolithiasis
Official Title
Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Urolithiasis in Children and Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis, Ureterolithiases
Keywords
Kidney Stone, Renal, Renal Stone
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Patients will receive both the clinically indicated and extremely low dose CT exams
Intervention Type
Diagnostic Test
Intervention Name(s)
Extremely low dose CT
Intervention Description
Patients undergoing clinically indicated CT will also receive the extremely low dose CT
Primary Outcome Measure Information:
Title
Diagnostic performance of extremely low dose CT
Description
Sensitivity
Time Frame
Immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew T Trout, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center Burnet Campus
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data sharing
Learn more about this trial
Validation of Low Dose CT for Diagnosis of Urolithiasis
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