Low-dose Contrast Media for Low-kVp Abdomen CT

Sponsor

Seoul St. Mary's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05878665

Collaborator

GE Healthcare (Industry)

292

Enrollment

Arm

18.6

Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Appendicitis Acute	Diagnostic Test: Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

292 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Apr 15, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Double low-dose CT 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 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.

Arm

Intervention/Treatment

Experimental: Double low-dose CT

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

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.

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy for acute appendicitis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 44 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul St. Mary's Hospital
GE Healthcare

Investigators

Principal Investigator: Bohyun Kim, MD, PhD, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bohyun Kim, Associate professor, Seoul St. Mary's Hospital

ClinicalTrials.gov Identifier:

NCT05878665

Other Study ID Numbers:

DLD-001

First Posted:

May 26, 2023

Last Update Posted:

May 26, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bohyun Kim, Associate professor, Seoul St. Mary's Hospital

acute appendicitis

acute abdomen

Additional relevant MeSH terms:

Appendicitis

Study Results

No Results Posted as of May 26, 2023