Computed Tomography Evaluation of Urinary Stones Densities Compared to in Vitro Analysis of Its Chemical Composition

February 1, 2020 updated by: Somia Usama Mohamed Rabea, Assiut University
The ability to predict stone composition, which influences patient treatment, depends on the accurate measurement of CT attenuation of stones. We will study the effects of stone composition, stone size, and scan collimation width on the measurement of attenuation in vitro.

Study Overview

Status

Unknown

Conditions

Detailed Description

Recently, the use of noncontrast spiral computerized tomography (NCCT) has gained widespread acceptance in the evaluation of urinary stone patients. It has long been used clinically to evaluate the causes of radiolucent filling defects using Hounsfield units (HU) to distinguish calculi from tumor or blood clots, and to identify nonurologic causes of flank pain (Smith R etal ). Urinary stones have a significantly higher CT attenuation than the surrounding soft tissues and are virtually always visible on NCCT. Knowing the composition of a urinary calculus is frequently a key factor in determining its most appropriate management. Should the urine be alkalinized? Will the stone be amenable to extracorporeal shock wave lithotripsy (ESWL), or should ureteroscopy or percutaneous lithotripsy be attempted? Different techniques have been used to assist in determining the correct chemical composition of calculi. Urine pH, urinary crystals, prior stone history and the presence of urea-splitting organisms (Ramakumar S,etal). Several in vitro studies have suggested that NCCT can demonstrate measured differences in radiodensity among different urinary stones (Mitchenson HD etal,).With these clinical problems in mind, we sought to determine whether the composition of urinary calculi could be predicted by their CT characteristics in an attempt to find out the best technique for distinguishing the various stones compositions, provided that it is clinically practical and would not require repeated imaging of the patients.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected or known urinary stone disease and were included in the study who attend to out patient clinic of Urology department of Assiut university hospital or admitted in the ward.

Description

Inclusion Criteria:

  • Any Age will be included .
  • Patient with suspected or known urinary stone disease.
  • Eligible for doing NCCT.
  • Giving written consent to participate

Exclusion Criteria:

  • Patient with classical NCCT contraindication like morbid obesity and pregnancy .
  • Patients with urinary stones will be treated by ESWL
  • Refusal participation .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of CT densities of urinary stones with its chemical composition
Time Frame: Baseline
determination whether the composition of urinary calculi could be predicted by their CT characteristics in an attempt to find out the best technique for distinguishing the various stones compositions .
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 30, 2020

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

October 30, 2022

Study Registration Dates

First Submitted

September 28, 2019

First Submitted That Met QC Criteria

September 28, 2019

First Posted (ACTUAL)

October 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 1, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT of urinary stones densities

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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