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Recruiting NCT05878665

Low-dose Contrast Media for Low-kVp Abdomen CT

No phase Interventional Appendicitis Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT.
Who it may be relevant to
Registry conditions: Appendicitis Acute. Basic parameters: 19 years — 44 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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?

Interventions

  • 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.

Primary outcome measures

  • Diagnostic accuracy for acute appendicitis [Time frame: For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

South Korea · 1 center
  • Seoul St. Mary's Hospital — Seoul

Identifiers

NCT: NCT05878665 · DLD-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗