Validation of Low Dose CT for Diagnosis of Urolithiasis

NCT ID: NCT03656913

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-09-28

Brief Summary

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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

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Conditions

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Nephrolithiasis Ureterolithiases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

Patients will receive both the clinically indicated and extremely low dose CT exams

Group Type EXPERIMENTAL

Extremely low dose CT

Intervention Type DIAGNOSTIC_TEST

Patients undergoing clinically indicated CT will also receive the extremely low dose CT

Interventions

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Extremely low dose CT

Patients undergoing clinically indicated CT will also receive the extremely low dose CT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

4 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew T Trout, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center Burnet Campus

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2018-5183

Identifier Type: -

Identifier Source: org_study_id

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