NCT03656913

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

August 31, 2018

Last Update Submit

February 17, 2021

Conditions

NephrolithiasisUreterolithiases

Keywords

Kidney StoneRenalRenal Stone

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of extremely low dose CT

    Sensitivity

    Immediate

Study Arms (1)

Study Group

EXPERIMENTAL

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

Diagnostic Test: Extremely low dose CT

Interventions

Extremely low dose CTDIAGNOSTIC_TEST

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

Study Group

Eligibility Criteria

Age4 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center Burnet Campus

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

NephrolithiasisUreterolithiasisKidney Calculi

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesUreteral DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew T Trout, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 4, 2018

Study Start

November 30, 2018

Primary Completion

September 28, 2020

Study Completion

September 28, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

No data sharing

Locations

US(1)