A Study on the Verification of Kidney CT Non-inferiority Using Low Concentration Contrast Agent

April 16, 2023 updated by: June Young Seo, Seoul National University Hospital

Low Tube Voltage Kidney Computed Tomography Using Low Concentration Iodine Contrast Agent: A Comparison Study With Conventional CT Protocol

This prospective study aims to evaluate clinical usefulness of low-voltage renal CT using low-concentration contrast agent and to compare with existing imaging techniques.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

88

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

Study Locations

  • Korea, Republic of
    • Jong-no Gu
      • Seoul, Jong-no Gu, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • 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

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who need contrast enhanced CT scan for anatomical evaluation of kidney

Description

Inclusion Criteria:

  • Subjects with no abnormalities in renal function (Serum creatinine < 1.4 mg/dl , GFR > 45mL/min/1.73 m2) in blood tests performed within one month
  • Those who understand the contents of the research subject explanation and voluntarily sign the consent form

Exclusion Criteria:

  • Body mass index > 30
  • Subjects whose renal function abnormality was confirmed in a blood test (Serum creatinine > 1.4 mg/dl , GFR < 45mL/min/1.73 m2) conducted within one month
  • Diabetic patients taking metformin
  • Those with a history of urinary tract obstruction
  • Those with a history of bladder, urinary tract, or kidney surgery that may affect the evaluation of the contrast agent in the renal parenchyma
  • Those whose anatomical deformities have been identified in previous images that may interfere with image analysis
  • Those who know or have been reported to have a history of contrast agent side effects in previous CT scans
  • Those with a history of hypersensitivity or adverse reactions to iobrix (intravascular CT contrast) or iodine based agent
  • Those with severe thyroid disease
  • Pregnancy
  • Those who are judged unsuitable for clinical trials by the researcher for reasons such as having other severe diseases or being judged to have a high risk of adverse reactions to intravascular contrast agents

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Renal CT evaluation
Patients who are planned kidney contrast enhanced CT scan
Diagnostic test: Contrast enhanced Kidney CT
  • Test group : Patient undergoing CT scan with 80kVP protocol and using low concentration intravascular contrast media ( Iobrix 270 mgl/MI , Taejoon pharm, Seoul, South Korea)
  • Control group : Patient undergoing CT scan with 120kVP protocol and using high concentration intravascular contrast media ( Iobrix 320 mgl/MI , Taejoon pharm, Seoul, South Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative analysis - Radiation dose
Time Frame: 6 months after the CT scan
Effective radiation dose (mSv) annotated on CT image
6 months after the CT scan
Quantitative analysis - Signal to noise ratio
Time Frame: 6 months after the CT scan
Value calculated by ( mean attenuation / standard deviation of attenuation of contrast area)
6 months after the CT scan
Quantitative analysis - Contrast to noise ratio
Time Frame: 6 months after the CT scan
Value calculated by [ ( mean attenuation - attenuation of contrast area) / standard deviation of attenuation of contrast area ]
6 months after the CT scan
Qualitative analysis - Diagnostic acceptability, Noise , Artifacts , Sharpness
Time Frame: 6 months after the CT scan
4 points scale quantitative analysis evaluated by three different radiologists
6 months after the CT scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnoses of focal lesion and inter-observer agreement
Time Frame: 6 months after the CT scan
Detection by three individual radiologist and its inter-observer agreement
6 months after the CT scan

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Taejoon Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: June Young Seo, MD, Seoul National University Hospital

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.

General Publications

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 (Actual)

January 20, 2023

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2022-0218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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