Abdominal AbscessNCT03681665
Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT
An observational study of Abdominal Abscess, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Abdominal Abscess
- What is being tested?
- ultralow dose abdominopelvic CT
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2018to 18 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected abdominal abscess from a tertiary care clinic.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
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.
- Conditions
- Abdominal Abscess
- Being tested
- ultralow dose abdominopelvic CT
- Medical subject headings
- Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultralow dose abdominopelvic CTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Abscess | Patients group with abdominal abscess Receives: Other: ultralow dose abdominopelvic CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start29 Jun 2018
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal AbscessStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681665
- Sponsor's protocol ID
- 4-2015-0413
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT
- ClinicalTrials.gov ID
- NCT03681665
- Acronym / sponsor ID
- 4-2015-0413
- Conditions
- Abdominal Abscess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abscess | – | Other: ultralow dose abdominopelvic CTPatients group with abdominal abscess |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected abdominal abscess from a tertiary care clinic.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultralow dose abdominopelvic CTIn 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. | Other | Abscess |
Primary outcome
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 secondary outcome
Effective radiation dose: CTDIvol(volume CT dose index), DLP(dose length product), effective dose(DLPx0.015)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Abscess, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of subjective image quality of CT image (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.