NCT02556983

CT Dose Simulation Study for Appendicitis

Optimizing the Radiation Dose for CT Imaging With Iterative Reconstruction in Diagnosing Acute Appendicitis: Dose Simulation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Appendicitis

Interventions

Type	Name	Description
RADIATION	CT	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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-02-01
• Completion: 2017-03-01
• First posted: 2015-09-22
• Last updated: 2017-04-12

Locations

1 site across 1 country: South Korea