Low-dose Contrast Media for Low-kVp Abdomen CT

NCT ID: NCT05878665

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Appendicitis Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Double low-dose CT

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

Bohyun Kim

OTHER

Sponsor Role lead

Responsible Party

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Bohyun Kim

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bohyun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Bohyun Kim, MD, PhD

Role: CONTACT

82-2-2258-5793

Facility Contacts

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Bohyun Kim

Role: primary

Other Identifiers

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DLD-001

Identifier Type: -

Identifier Source: org_study_id

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