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Chest CT Using Low-concentration Iodine Contrast Media

Primary Purpose

Pulmonary Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Iohexol (320mgI/mL) with 120kVp
Iohexol (320mgI/mL) with 100kVp
Iohexol (270mgI/mL) with 100kVp
Iohexol (240mgI/mL) with 100kVp
Sponsored by
Jung Im Jung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone Exclusion Criteria: Under the age of 18 Cases where contrast-enhanced CT cannot be performed Heart failure Pregnancy If patients cannot voluntarily give written consent to participate in this clinical trial In the case of an anatomical deformation that may interfere with image analysis in the previous image Patients with a history of hypersensitivity to IOBRIX, components of IOBRIX, and iodine-based drugs Patients with severe thyroid disease (Iodine may accumulate in the thyroid gland and worsen symptoms.) Those who are judged unsuitable by the tester for other reasons Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone

Sites / Locations

  • Seoul St. Mary's Hospital, The Catholic University of Korea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Chest CT evaluation (Administrate contrast media for CECT)

Chest CT evaluation (Experimental 1)

Chest CT evaluation (Experimental 2)

Chest CT evaluation (Experimental 3)

Arm Description

Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the conventional tube voltage

Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the low tube voltage

Patients who are planned chest contrast enhanced CT scan ; Low concentration iodine contrast agents with the low tube voltage)

Patients who are planned chest contrast enhanced CT scan; Ultra Low concentration iodine contrast agents with the low tube voltage)

Outcomes

Primary Outcome Measures

Anatomic depiction (including image sharpness)
3 points scale qualitative analysis evaluated by two different radiologists (Poor, moderate, excellent)
Noise
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
Contrast-related artifact
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
Overall diagnostic acceptability
5 points scale qualitative analysis evaluated by two different radiologists (Non-diagnostic, suboptimal, standard, better than standard, Excellent)

Secondary Outcome Measures

Full Information

First Posted
July 13, 2023
Last Updated
October 18, 2023
Sponsor
Jung Im Jung
Collaborators
Taejoon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05967117
Brief Title
Chest CT Using Low-concentration Iodine Contrast Media
Official Title
Chest CT Using Low-concentration Iodine Contrast Media - a Prospective Multicenter Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jung Im Jung
Collaborators
Taejoon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the quality of images when low-concentration iodine contrast agents is used in chest CT with low tube voltage and if they can be used in routine imaging. The primary endpoint of the study was the quality of the image and comparison of chest CT by using low and conventional concentration iodine contrast agents with low tube voltage and chest CT by using the conventional concentration iodine contrast agents with the conventional tube voltage; The secondary endpoint is optimizing chest CT protocol using an iodine contrast agent.
Detailed Description
With persistent advances in computed tomography (CT) technology, there is a need for continuous investigation and optimization of injection protocols. Intravenous contrast enhancement in CT is affected by various interacting factors, which can be roughly divided into 3 categories: patient, contrast medium and CT scanning. Over the last decade, evolutions in technology has resulted in faster CTs with improved temporal and spatial resolutions; newer techniques such as iterative reconstruction has enabled lower tube voltage (expressed in units of peak kiloVolt, kVp) and lower dose CTs with less noise and preserved image quality. As CT scanning is one of the major determinants of contrast enhancement at CT, such technological advances in CT can be assumed to have invariably caused alterations in the degree of contrast enhancement at CT. However, despite changes in CT scanning techniques, recommended contrast injection protocol for chest CT with enhancement (CECT), including concentration of iodine contrast material, have not changed over the last decade; for routine chest CECT, the use of 300-350 mgI/ml iodine contrast material has been recommended without definitely stating the precise reasons using that specific iodine concentration. Therefore, the aim of this study was to evaluate the image quality of low voltage chest CECT using LCCM(Low-Concentration Iodinated Contrast Media.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chest CT evaluation (Administrate contrast media for CECT)
Arm Type
Active Comparator
Arm Description
Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the conventional tube voltage
Arm Title
Chest CT evaluation (Experimental 1)
Arm Type
Experimental
Arm Description
Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the low tube voltage
Arm Title
Chest CT evaluation (Experimental 2)
Arm Type
Experimental
Arm Description
Patients who are planned chest contrast enhanced CT scan ; Low concentration iodine contrast agents with the low tube voltage)
Arm Title
Chest CT evaluation (Experimental 3)
Arm Type
Experimental
Arm Description
Patients who are planned chest contrast enhanced CT scan; Ultra Low concentration iodine contrast agents with the low tube voltage)
Intervention Type
Drug
Intervention Name(s)
Iohexol (320mgI/mL) with 120kVp
Other Intervention Name(s)
Iobrix inj. 320
Intervention Description
Patient undergoing CT scan with 120kVp protocol and using Iobrix inj. 320 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.
Intervention Type
Drug
Intervention Name(s)
Iohexol (320mgI/mL) with 100kVp
Other Intervention Name(s)
Iobrix inj. 320
Intervention Description
Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 320 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.
Intervention Type
Drug
Intervention Name(s)
Iohexol (270mgI/mL) with 100kVp
Other Intervention Name(s)
Iobrix inj. 270
Intervention Description
Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 270 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.
Intervention Type
Drug
Intervention Name(s)
Iohexol (240mgI/mL) with 100kVp
Other Intervention Name(s)
Iobrix inj. 240
Intervention Description
Patient undergoing CT scan with 100kVp protocol and using Iobrix inj. 240 (Taejoon pharm, Seoul, South Korea). CT images were obtained 55sec after Contrast media injection(100mL, 2mL/sec) with 20mL saline flushing.
Primary Outcome Measure Information:
Title
Anatomic depiction (including image sharpness)
Description
3 points scale qualitative analysis evaluated by two different radiologists (Poor, moderate, excellent)
Time Frame
12 months after the CT scan (Chest contrast-enhanced CT is a 1-day procedure, but evaluating all the images will be done one year after the 1st CT scan.)
Title
Noise
Description
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
Time Frame
12 months after the CT scan
Title
Contrast-related artifact
Description
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
Time Frame
12 months after the CT scan
Title
Overall diagnostic acceptability
Description
5 points scale qualitative analysis evaluated by two different radiologists (Non-diagnostic, suboptimal, standard, better than standard, Excellent)
Time Frame
12 months after the CT scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone Exclusion Criteria: Under the age of 18 Cases where contrast-enhanced CT cannot be performed Heart failure Pregnancy If patients cannot voluntarily give written consent to participate in this clinical trial In the case of an anatomical deformation that may interfere with image analysis in the previous image Patients with a history of hypersensitivity to IOBRIX, components of IOBRIX, and iodine-based drugs Patients with severe thyroid disease (Iodine may accumulate in the thyroid gland and worsen symptoms.) Those who are judged unsuitable by the tester for other reasons Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung IM Jung, MD, PhD
Phone
+822-2258-1456
Email
jijung@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Im Jung, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Department of Radiology
Phone
+822-2258-1456
Email
oasis5noel@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Chest CT Using Low-concentration Iodine Contrast Media

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