Low-dose Contrast Media for Low-kVp Abdomen CT

NCT05878665 | Recruiting

• 1 other identifier: DLD-001
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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?

Conditions

Appendicitis Acute

Keywords

acute appendicitis; acute abdomen; CT

Outcome Measures

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.

  For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU

Study Arms (1)

Double low-dose CT

EXPERIMENTAL

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

Interventions

Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT DIAGNOSTIC_TEST

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.

Double low-dose CT

Eligibility Criteria

• Age: 19 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bohyun Kim: lead
• GE Healthcare: collaborator

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Appendicitis; Abdomen, Acute

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Bohyun Kim, MD, PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bohyun Kim, MD, PhD

CONTACT

82-2-2258-5793; kbh@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 26, 2023
• Study Start: December 21, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)