- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03681665
Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT
September 27, 2020 updated by: Yonsei University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 03722
- Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with suspected abdominal abscess from a tertiary care clinic.
Description
Inclusion Criteria:
- patients who underwent standard dose CT for suspected intraabdominal abscess
- patients who need follow-up CT to evaluate treatment response of abscess 3) Adult patient, 4) patients who agreed this study protocol
Exclusion Criteria:
- pregnancy
- patients with poor renal function (GFR < 30 mL/min/1/73m2)
- Patients who have allergy to CT contrast media
- Patients who are not cooperative (e.g., dementia)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Abscess
Patients group with abdominal abscess
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of subjective image quality of CT image
Time Frame: 1 month
|
Score of subjective image quality of CT images consists of overall subjective image quality, noise, diagnostic ability, and artifact.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective radiation dose: CTDIvol(volume CT dose index), DLP(dose length product), effective dose(DLPx0.015)
Time Frame: 1 month
|
Effective radiation dose between standard dose CT and ultra-low dose CT will be compared
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2018
Primary Completion (Actual)
March 18, 2019
Study Completion (Actual)
March 18, 2019
Study Registration Dates
First Submitted
September 17, 2018
First Submitted That Met QC Criteria
September 20, 2018
First Posted (Actual)
September 24, 2018
Study Record Updates
Last Update Posted (Actual)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 27, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2015-0413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on ultralow dose abdominopelvic CT
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-
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