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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
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nephrolithiasis focused on measuring Kidney Stone, Renal, Renal Stone

Eligibility Criteria

4 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 31, 2018
Last Updated
February 17, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
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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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