Appendicitis AcuteNCT05878665
Low-dose Contrast Media for Low-kVp Abdomen CT
A study testing Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT in people with Appendicitis Acute, run by Bohyun Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 44 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Dec 2023to 4 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients who decline to participate
- Contraindications to contrast-enhanced CT (eGFR < 30 mL/min/173 m^2 or pregnant)
- BMI >= 30.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Low-dose Contrast Media Protocol for Low-kVp Abdominopelvic CT in Suspected Acute Appendicitis
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:
- Can low-dose contrast media paired with low-dose radiation CT of the abdomen provide acceptable diagnostic accuracy in acute appendicitis?
- How much radiation dose can be saved by using low radiation dose abdominal CT in combination with low dose contrast media?
- Conditions
- Appendicitis Acute
- Being tested
- Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT
- Keywords
- acute appendicitis, acute abdomen, CT
- Medical subject headings
- Appendicitis, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Double low-dose CT | Experimental | Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT Receives: Diagnostic Test: Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start21 Dec 2023
- Primary completion26 Jul 2026
- Study completion4 Sep 2026
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bohyun Kim
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor-investigator, Bohyun Kim, Seoul St. Mary's Hospital
- Investigators
- Bohyun Kim, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878665
- Sponsor's protocol ID
- DLD-001
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Low-dose Contrast Media Protocol for Low-kVp Abdominopelvic CT in Suspected Acute Appendicitis
- ClinicalTrials.gov ID
- NCT05878665
- Acronym / sponsor ID
- DLD-001
- Conditions
- Appendicitis Acute
- Keywords
- acute appendicitis, acute abdomen, CT
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Bohyun KimUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 26 Jul 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can low-dose contrast media paired with low-dose radiation CT of the abdomen provide acceptable diagnostic accuracy in acute appendicitis?
- How much radiation dose can be saved by using low radiation dose abdominal CT in combination with low dose contrast media?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double low-dose CT | Experimental | Diagnostic Test: Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CTWeight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who decline to participate
- Contraindications to contrast-enhanced CT (eGFR < 30 mL/min/173 m^2 or pregnant)
- BMI >= 30.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CTThe 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. | Diagnostic test | Double low-dose CT |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bohyun Kim, MD, PhD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-adjusted low-dose contrast media paired with low-radiation dose abdomen CT in people with Appendicitis Acute, run by Bohyun Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy for acute appendicitis (time frame: For operated patients, postop. period (up to 1 month); If non-operated, at 6 months-FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.