NCT03681665

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 17, 2018

Last Update Submit

September 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Effective radiation dose: CTDIvol(volume CT dose index), DLP(dose length product), effective dose(DLPx0.015)

    1 month

Study Arms (1)

Abscess

Patients group with abdominal abscess

Other: ultralow dose abdominopelvic CT

Interventions

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.

Abscess

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected abdominal abscess from a tertiary care clinic.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Abdominal Abscess

Condition Hierarchy (Ancestors)

AbscessSuppurationInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 24, 2018

Study Start

June 29, 2018

Primary Completion

March 18, 2019

Study Completion

March 18, 2019

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations