Low-dose Contrast Media for Low-kVp Abdomen CT
ConditionAppendicitis Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-44
SponsorBohyun Kim
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who decline to participate
Contraindications to contrast-enhanced CT (eGFR < 30 mL/min/173 m² or pregnant)
BMI >= 30.
Trial design
Design model
Single group
Treatments tested in this trial
Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT
Diagnostic testThe 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.
Treatment groups
292 Participants
are divided into 1 treatment groupGroup A: Double low-dose CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy for acute appendicitis
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.
Time frame
For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FUSponsors and contacts
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Source ClinicalTrials.gov