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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03681665
Other study ID # 4-2015-0413
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2018
Est. completion date March 18, 2019

Study information

Verified date September 2020
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Increasing radiation exposure by medical examinations is getting more concerns. For optimal medical imaging, reducing radiation exposure with preservation image quality is important. One of the solutions is use of iterative recontruction of CT examination. In this study, the investigators aimed to investigate the clinical feasibility of ultralow dose abdominopelvic CT with iterative reconstruction in patients with intraabdominal abscess. Patients with intrabdominal abscess usually undergo multiple CT examinations to evaluate treatment response. Therefore, ultralow dose CT can reduce unnecessary radiation exposure in these patients.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 18, 2019
Est. primary completion date March 18, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility Inclusion Criteria:

1. patients who underwent standard dose CT for suspected intraabdominal abscess

2. patients who need follow-up CT to evaluate treatment response of abscess 3) Adult patient, 4) patients who agreed this study protocol

Exclusion Criteria:

1. pregnancy

2. patients with poor renal function (GFR < 30 mL/min/1/73m2)

3. Patients who have allergy to CT contrast media

4. Patients who are not cooperative (e.g., dementia)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ultralow dose abdominopelvic CT
In the patient cohort with abdominal abscess, ultralow dose abdominopelvic CT will be performed as a follow-up protocol. Ultralow dose CT has approximately 80~90% reduced radiation dose compared to standard dose CT.

Locations

Country Name City State
Korea, Republic of Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score of subjective image quality of CT image Score of subjective image quality of CT images consists of overall subjective image quality, noise, diagnostic ability, and artifact. 1 month
Secondary Effective radiation dose: CTDIvol(volume CT dose index), DLP(dose length product), effective dose(DLPx0.015) Effective radiation dose between standard dose CT and ultra-low dose CT will be compared 1 month
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