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Terminated

NCT Number: NCT05878665

Low-dose Contrast Media for Low-kVp Abdomen CT

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?

Why the study stopped: Enrollment closed before reaching the planned target because of slower than expected accrual. Data from 109 prospectively enrolled participants were judged sufficient to address the primary objective and the primary outcome.
Terminated

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Key information

Conditions

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

Age range

19 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic accuracy for acute appendicitis

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Bohyun Kim

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 26, 2023
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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