Low-dose Contrast Media for Low-kVp Abdomen CT

May 21, 2025 updated by: Bohyun Kim

Optimizing Low-dose Contrast Media Protocol for Low-kVp Abdominopelvic CT in Suspected Acute Appendicitis

The purpose of this clinical study is to test the performance of low radiation dose abdominal CT combined with low dose contrast media for the diagnosis of acute appendicitis in young patients. The main questions to be answered are:

1, Can low-dose contrast media paired with low-dose radiation CT of the abdomen provide acceptable diagnostic accuracy in acute appendicitis? 2. How much radiation dose can be saved by using low radiation dose abdominal CT in combination with low dose contrast media?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

292

Phase

  • Not Applicable

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
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St. Mary'S Hospital
        • Contact:
          • Bohyun Kim

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

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients in the emergency department with suspected acute appendicitis based on clinical examination
  • Patients scheduled for contrast-enhanced CT of the abdomen and pelvis for diagnosis of suspected acute appendicitis.

Exclusion criteria:

  • Patients who decline to participate
  • Contraindications to contrast-enhanced CT (eGFR < 30 mL/min/173 m^2 or pregnant)
  • BMI >= 30.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double low-dose CT
Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT
Diagnostic test: Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT
The investigators are aiming for a 10% reduction in iodine dosage at 10 kVp reduction in CT radiation. Routine iodine dosing is 0.521 g I/kg at 120 kVp. Therefore, at 90 kVp, a 30% reduction in iodine dosing is expected, which is 0.365 g I/kg. At 100 kVp, the iodine dosage is reduced to 0.417 g I/kg, which is a 20% reduction. The kVp value is automatically selected by the CT device according to the body habitus, which is a clinical routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy for acute appendicitis
Time Frame: For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU
The primary outcome of the study is the diagnostic accuracy of double low-dose CT for acute appendicitis in young adults with suspected acute appendicitis. Based on the CT findings, a three-tiered diagnosis of appendicitis will be given (no appendicitis, uncomplicated appendicitis, or complicated appendicitis). In the case of no appendicitis, a possible alternative diagnosis is given. The reference standard for appendicitis is operative findings and surgical pathology reports. In nonoperative cases, sequential radiologic evaluation, clinical follow-up, and the judgment of the attending physician will conclude the diagnosis. Specifically, if the patient is not treated for recurrent symptoms within 6 months, the radiologic diagnosis of CT findings is considered valid. The diagnostic accuracy for acute appendicitis is true positive for acute appendicitis and true negative for acute appendicitis divided by all participants.
For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU

Collaborators and Investigators

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

Sponsor

Bohyun Kim

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Bohyun Kim, MD, PhD, Seoul St. Mary'S Hospital

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)

December 21, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLD-001

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

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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