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Low-dose Contrast Media for Low-kVp Abdomen CT

Primary Purpose

Appendicitis Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis Acute focused on measuring acute appendicitis, acute abdomen, CT

Eligibility Criteria

19 Years - 44 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Double low-dose CT

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2023
    Last Updated
    May 18, 2023
    Sponsor
    Seoul St. Mary's Hospital
    Collaborators
    GE Healthcare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05878665
    Brief Title
    Low-dose Contrast Media for Low-kVp Abdomen CT
    Official Title
    Optimizing Low-dose Contrast Media Protocol for Low-kVp Abdominopelvic CT in Suspected Acute Appendicitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    April 15, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul St. Mary's Hospital
    Collaborators
    GE Healthcare

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appendicitis Acute
    Keywords
    acute appendicitis, acute abdomen, CT

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    292 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Double low-dose CT
    Arm Type
    Experimental
    Arm Description
    Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT
    Intervention Description
    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 Outcome Measure Information:
    Title
    Diagnostic accuracy for acute appendicitis
    Description
    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.
    Time Frame
    For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bohyun Kim, MD, PhD
    Phone
    82-2-2258-5793
    Email
    kbh@catholic.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bohyun Kim, MD, PhD
    Organizational Affiliation
    Seoul St. Mary's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Low-dose Contrast Media for Low-kVp Abdomen CT

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