AppendicitisNCT02556983
CT Dose Simulation Study for Appendicitis
An observational study of Appendicitis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute appendicitis, by using of dose simulation technique and iterative reconstruction. Read more about this study
- Who is it for?
- Ages 15 to 44 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- CT
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Mar 2017
- Phase
- Observational
- 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 15 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Emergency department visit with suspected symptoms and signs of acute appendicitis.
Who may be able to join
- 18-44 years of age.
- Emergency department visit with suspected symptoms and signs of acute appendicitis
- Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis
Who cannot join
- having contraindications of intravenous contrast agent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bunadang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Optimizing the Radiation Dose for CT Imaging With Iterative Reconstruction in Diagnosing Acute Appendicitis: Dose Simulation Study
The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute appendicitis, by using of dose simulation technique and iterative reconstruction.
Read the detailed description
Three sequential non-inferiority tests are planned. First, three readers will review the original 2-mSv images. Second, the readers will review the 75%-dose images. After the readers review the 75%-dose images and before the readers reviewed the 50%-dose images, the non-inferiority of 75% dose to the original dose will be tested. If the non-inferiority is not accepted, the study will be terminated with the conclusion of 2 mSv as the lowest acceptable dose. If the non-inferiority is accepted, the study will be continue to the next step. In the same manner, the readers will review the next lower-dose images (50% and then 25%), and then the noninferiority will be tested against the original dose.
- Conditions
- Appendicitis
- Being tested
- CT
- Keywords
- Appendicitis, Tomography, X-Ray Computed, Receiver operating characteristic (ROC) Curve, Computer Simulation
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTRadiation
Contrast-enhanced CT images of the abdomen and pelvis will be obtained during the portal venous phase using a 256-channel CT system (Philips Healthcare, Cleveland, OH). The target median dose-length product (DLP) is 130 mGy·cm, which corresponded to an effective dose of 2 mSv with a conversion factor of 0.015 mSv·mGy-1·cm-1. The radiation output was automatically adjusted according to the individual patient's body size.
| Study group | Role | What they receive |
|---|---|---|
| Suspected appendicitis | Patients who are suspected as having acute appendicitis Receives: Radiation: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
The pooled area under curve (AUC) from three radiologists
Measured: 2 months
Diagnostic performance at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
The pooled AUC from three radiologists
Measured: 1 months
Diagnostic performance at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
*The analysis of 50%-dose CT images will be performed only if non-inferiority of 75%-dose CT to the original CT is proven in terms of the pooled AUC.
The pooled AUC from three radiologists
Measured: 8 months
Diagnostic performance at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
*The analysis of 25%-dose CT images will be performed only if non-inferiority of 50%-dose CT is proven to the original CT in terms of the pooled AUC.
The pooled AUC from three radiologists
Measured: 14 months
Secondary outcomes (24)
Sensitivity at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
For calculation of sensitivity and specificity, the 5-grade scores are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
Measured: 2 months
Specificity at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
For calculation of sensitivity and specificity, the 5-grade scores are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
Measured: 2 months
Sensitivity at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
For calculation of sensitivity and specificity, the 5-grade scores are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
Measured: 1 month
Specificity at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
For calculation of sensitivity and specificity, the 5-grade scores are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
Measured: 1 month
Sensitivity at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
For calculation of sensitivity and specificity, the 5-grade scores are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
Measured: 8 months
Specificity at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
For calculation of sensitivity and specificity, the 5-grade scores are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
Measured: 8 months
Sensitivity at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
For calculation of sensitivity and specificity, the 5-grade scores are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
Measured: 14 months
Specificity at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
For calculation of sensitivity and specificity, the 5-grade scores are collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.
Measured: 14 months
Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: the likelihood score for appendicitis
Likelihood score for appendicitis in patients confirmed as having appendicitis Likelihood score for appendicitis in patients confirmed as not having appendicitis
Measured: 2 months
Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: the likelihood score for appendicitis
Likelihood score for appendicitis in patients confirmed as having appendicitis Likelihood score for appendicitis in patients confirmed as not having appendicitis
Measured: 1 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: the likelihood score for appendicitis
Likelihood score for appendicitis in patients confirmed as having appendicitis Likelihood score for appendicitis in patients confirmed as not having appendicitis
Measured: 8 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: the likelihood score for appendicitis
Likelihood score for appendicitis in patients confirmed as having appendicitis Likelihood score for appendicitis in patients confirmed as not having appendicitis
Measured: 14 month
Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: normal appendix visualization rate
The frequency of normal appendix visualization at CT
Measured: 2 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: normal appendix visualization rate
The frequency of normal appendix visualization at CT
Measured: 1 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: normal appendix visualization rate
The frequency of normal appendix visualization at CT
Measured: 8 months
Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: normal appendix visualization rate
The frequency of normal appendix visualization at CT
Measured: 14 months
Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: indeterminate CT interpretation
The frequency of indeterminate CT interpretation (grade 3)
Measured: 2 months
Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: indeterminate CT interpretation
The frequency of indeterminate CT interpretation (grade 3)
Measured: 1 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: indeterminate CT interpretation
The frequency of indeterminate CT interpretation (grade 3)
Measured: 8 months
Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: indeterminate CT interpretation
The frequency of indeterminate CT interpretation (grade 3)
Measured: 14 months
Alternative diagnoses at original CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
The numbers of important alternative diagnoses established
Measured: 2 months
Alternative diagnoses at 75%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
The numbers of important alternative diagnoses established
Measured: 1 month
Alternative diagnoses at 50%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
The numbers of important alternative diagnoses established
Measured: 8 months
Alternative diagnoses at 25%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
The numbers of important alternative diagnoses established
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hoon Park, Seoul National University Bundang Hospital
- Investigators
- Ji Hoon Park, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556983
- Sponsor's protocol ID
- SNUBH-02-2015-030
- Status last verified
- Apr 2017
- First submitted
- 18 Sep 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Radiation Dose for CT Imaging With Iterative Reconstruction in Diagnosing Acute Appendicitis: Dose Simulation Study
- ClinicalTrials.gov ID
- NCT02556983
- Acronym / sponsor ID
- SNUBH-02-2015-030
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Tomography, X-Ray Computed, Receiver operating characteristic (ROC) Curve, Computer Simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Sep 2015 (estimated)
- 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 study will explore CT radiation dose as low as reasonably achievable in diagnosing acute appendicitis, by using of dose simulation technique and iterative reconstruction.
Detailed description
Three sequential non-inferiority tests are planned. First, three readers will review the original 2-mSv images. Second, the readers will review the 75%-dose images. After the readers review the 75%-dose images and before the readers reviewed the 50%-dose images, the non-inferiority of 75% dose to the original dose will be tested. If the non-inferiority is not accepted, the study will be terminated with the conclusion of 2 mSv as the lowest acceptable dose. If the non-inferiority is accepted, the study will be continue to the next step. In the same manner, the readers will review the next lower-dose images (50% and then 25%), and then the noninferiority will be tested against the original dose.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected appendicitis | – | Radiation: CTPatients who are suspected as having acute appendicitis |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Emergency department visit with suspected symptoms and signs of acute appendicitis.
Key inclusion criteria (3 listed)
- 18-44 years of age.
- Emergency department visit with suspected symptoms and signs of acute appendicitis
- Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis
Key exclusion criteria (1 listed)
- having contraindications of intravenous contrast agent
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 |
|---|---|---|
| CTContrast-enhanced CT images of the abdomen and pelvis will be obtained during the portal venous phase using a 256-channel CT system (Philips Healthcare, Cleveland, OH). The target median dose-length product (DLP) is 130 mGy·cm, which corresponded to an effective dose of 2 mSv with a conversion factor of 0.015 mSv·mGy-1·cm-1. The radiation output was automatically adjusted according to the individual patient's body size. | Radiation | Suspected appendicitis |
Primary outcome
Diagnostic performance at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 2 months
The pooled area under curve (AUC) from three radiologists
Diagnostic performance at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 1 months
The pooled AUC from three radiologists
Diagnostic performance at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 8 months
*The analysis of 50%-dose CT images will be performed only if non-inferiority of 75%-dose CT to the original CT is proven in terms of the pooled AUC. The pooled AUC from three radiologists
Diagnostic performance at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 14 months
*The analysis of 25%-dose CT images will be performed only if non-inferiority of 50%-dose CT is proven to the original CT in terms of the pooled AUC. The pooled AUC from three radiologists
24 secondary outcomes
Sensitivity at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 2 months
Specificity at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 2 months
Sensitivity at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 1 month
Specificity at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 1 month
Sensitivity at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 8 months
Specificity at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 8 months
Sensitivity at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 14 months
Specificity at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
Time frame: 14 months
Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: the likelihood score for appendicitis
Time frame: 2 months
Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: the likelihood score for appendicitis
Time frame: 1 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: the likelihood score for appendicitis
Time frame: 8 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: the likelihood score for appendicitis
Time frame: 14 month
Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: normal appendix visualization rate
Time frame: 2 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: normal appendix visualization rate
Time frame: 1 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: normal appendix visualization rate
Time frame: 8 months
Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: normal appendix visualization rate
Time frame: 14 months
Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: indeterminate CT interpretation
Time frame: 2 months
Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: indeterminate CT interpretation
Time frame: 1 month
Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: indeterminate CT interpretation
Time frame: 8 months
Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: indeterminate CT interpretation
Time frame: 14 months
Alternative diagnoses at original CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
Time frame: 2 months
Alternative diagnoses at 75%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
Time frame: 1 month
Alternative diagnoses at 50%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
Time frame: 8 months
Alternative diagnoses at 25%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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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.
Ji Hoon Park, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by Seoul National University Bundang Hospital 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 12 Apr 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 performance at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist (time frame: 2 months). The study lists 4 primary outcomes in all. 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 12 Apr 2017.