Clinical trial NCT02556983: CT Dose Simulation Study for Appendicitis
Official title: Optimizing the Radiation Dose for CT Imaging With Iterative Reconstruction in Diagnosing Acute Appendicitis: Dose Simulation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Keywords: Appendicitis
Tomography, X-Ray Computed
Receiver operating characteristic (ROC) Curve
Computer Simulation
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency department visit with suspected symptoms and signs of acute appendicitis.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* having contraindications of intravenous contrast agent

Primary outcomes:
measure: Diagnostic performance at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 2 months
measure: Diagnostic performance at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 1 months
measure: Diagnostic performance at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 8 months
measure: Diagnostic performance at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 14 months
Secondary outcomes:
measure: Sensitivity at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 2 months
measure: Specificity at original dose (2 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 2 months
measure: Sensitivity at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 1 month
measure: Specificity at 75% dose (1.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 1 month
measure: Sensitivity at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 8 months
measure: Specificity at 50% dose (1.0 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 8 months
measure: Sensitivity at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 14 months
measure: Specificity at 25% dose (0.5 mSv) using 5-grade Likert score for the likelihood of appendicitis assigned by each radiologist
timeFrame: 14 months
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: the likelihood score for appendicitis
timeFrame: 2 months
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: the likelihood score for appendicitis
timeFrame: 1 month
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: the likelihood score for appendicitis
timeFrame: 8 month
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: the likelihood score for appendicitis
timeFrame: 14 month
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: normal appendix visualization rate
timeFrame: 2 month
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: normal appendix visualization rate
timeFrame: 1 month
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: normal appendix visualization rate
timeFrame: 8 months
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: normal appendix visualization rate
timeFrame: 14 months
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at original CT: indeterminate CT interpretation
timeFrame: 2 months
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 75%-dose CT: indeterminate CT interpretation
timeFrame: 1 month
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 50%-dose CT: indeterminate CT interpretation
timeFrame: 8 months
measure: Diagnostic confidence in diagnosing and ruling out appendicitis at 25%-dose CT: indeterminate CT interpretation
timeFrame: 14 months
measure: Alternative diagnoses at original CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
timeFrame: 2 months
measure: Alternative diagnoses at 75%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
timeFrame: 1 month
measure: Alternative diagnoses at 50%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
timeFrame: 8 months
measure: Alternative diagnoses at 25%-dose CT: the radiologists will record possible alternative diagnosis if the patients are presumed to be not having appendicitis
timeFrame: 14 months
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul National University Bunadang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ji Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References: