Actively Recruiting
Chest CT Using Low-concentration Iodine Contrast Media - a Prospective Multicenter Comparative Study
Led by Jung Im Jung · Updated on 2024-07-25
370
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Jung Im Jung
Lead Sponsor
T
Taejoon Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the quality of chest CT images using different concentrations of iodine contrast agents combined with varying tube voltages. The study aims to determine whether low-concentration iodine contrast media with low tube voltage can produce images suitable for routine chest CT scans. This research focuses on optimizing chest CT protocols and improving image quality while potentially reducing contrast agent concentration. Participants will receive one of four chest CT scan protocols: conventional iodine contrast with conventional tube voltage, conventional iodine contrast with low tube voltage, low-concentration iodine contrast with low tube voltage, or ultra-low-concentration iodine contrast with low tube voltage. The iodine contrast media used are different concentrations of Iohexol, administered intravenously with a 100 mL injection followed by saline flushing, and CT images are captured 55 seconds after injection. During the study, participants will undergo a contrast-enhanced chest CT scan following the assigned protocol. Researchers will evaluate image quality aspects such as anatomic depiction, noise, contrast-related artifacts, and overall diagnostic acceptability. These assessments will be done up to 12 months after the CT scan. The study involves a randomized and double-blind design, and participants will be monitored to optimize chest CT imaging protocols using iodine contrast agents.
CONDITIONS
Brief Title
Chest CT Using Low-concentration Iodine Contrast Media
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older
- Weigh less than 90 kg
- Have a body mass index (BMI) less than 30
- Undergoing contrast-enhanced chest CT scan alone
- Able to voluntarily provide written consent to participate
You will not qualify if you...
- Under 18 years of age
- Unable to undergo contrast-enhanced CT
- Have heart failure
- Are pregnant
- Have anatomical deformation interfering with image analysis
- History of hypersensitivity to IOBRIX, its components, or iodine-based drugs
- Have severe thyroid disease
- Judged unsuitable by the tester for other reasons related to safety or study participation suitability
- Unable to provide voluntary written consent to participate in this clinical trial if required by the study protocol or investigator judgment based on source text repetition of consent requirement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a chest contrast-enhanced CT scan using one of the specified iodine contrast media and tube voltage protocols.
1 visit (in-person)
Duration - 12 months
Participants' CT images are evaluated for image quality, noise, artifact, and diagnostic acceptability up to 12 months after the CT scan.
Assessments done remotely; no additional visits required
Trial Site Locations
Total: 6 locations
1
Bucheon St. Mary's Hospital, The Catholic University of Korea
Bucheon-si, Gyeonggi-do, South Korea, 14647
Completed
2
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Actively Recruiting
3
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907
Actively Recruiting
4
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Seocho-gu, South Korea, 06591
Actively Recruiting
5
Chonnam National University Hospital
Gwangju, South Korea, 61469
Completed
6
Seoul National University Hospital
Seoul, South Korea, 03080
Completed
Research Team
J
Jung IM Jung, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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