Low-dose Contrast Media for Low-kVp Abdomen CT

Not Applicable

Not yet recruiting

• Conditions: Appendicitis Acute
• Interventions: Diagnostic Test: Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT

• Registration Number: NCT05878665
• Lead Sponsor: Bohyun Kim

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Study Start: 2023-11-30
• Primary Completion: 2024-04-15
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double low-dose CT	Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT	Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy for acute appendicitis	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.