Low-dose Contrast Media for Low-kVp Abdomen CT

Appendicitis Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05878665
• Other study ID #: DLD-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Seoul St. Mary's Hospital
• Contact: Bohyun Kim, MD, PhD
• Phone: 82-2-2258-5793
• Email: kbh[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 292
• Est. completion date: December 31, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bohyun Kim	GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU