Actively Recruiting

Phase Not Applicable
Age: 19Years - 44Years
All Genders
ID05878665

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

Led by Bohyun Kim · Updated on 2025-05-28

292

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Bohyun Kim

Lead Sponsor

G

GE Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the use of low radiation dose abdominal CT combined with low dose contrast media to diagnose acute appendicitis in young patients. The main goals are to determine if this low-dose method can provide accurate diagnosis and how much radiation exposure can be reduced compared to standard CT scans. The study focuses on patients suspected of having acute appendicitis who are evaluated in the emergency department. Participants receive a weight-adjusted low-dose contrast media along with a low-radiation dose abdomen CT scan. The contrast media dose varies based on the CT device's automatic selection of the kVp value according to body size, aiming for a reduction in iodine dose by 10% to 30% depending on the kVp setting. The low-dose CT and contrast media protocol is designed to maintain diagnostic quality while lowering radiation and iodine exposure. During the study, participants will undergo the CT scan with this specialized low-dose protocol. Researchers will assess diagnostic accuracy for acute appendicitis, following operated patients for up to one month after surgery and non-operated patients for six months. The study includes monitoring for safety and effectiveness of the imaging method, with total participation time depending on patient treatment and follow-up visits.

CONDITIONS

Brief Title

Low-dose Contrast Media for Low-kVp Abdomen CT

Who Can Participate

Age: 19Years - 44Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Age between 19 and 44 years
Not Eligible

You will not qualify if you...

  • Patients who decline to participate
  • Contraindications to contrast-enhanced CT (eGFR < 30 mL/min/173 m² or pregnant)
  • Body mass index (BMI) of 30 or higher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day

Participants undergo a weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT to diagnose suspected acute appendicitis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are monitored for diagnostic accuracy outcomes, including postoperative follow-up if operated or clinical follow-up if non-operated.

Follow-up visits depending on surgery status

Trial Site Locations

Total: 1 location

1

Seoul St. Mary's Hospital

Seoul, South Korea, 06591

Actively Recruiting

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Research Team

B

Bohyun Kim, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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