NCT05967117

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
370

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

July 13, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 24, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

July 13, 2023

Last Update Submit

July 23, 2024

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

  • Anatomic depiction (including image sharpness)

    3 points scale qualitative analysis evaluated by two different radiologists (Poor, moderate, excellent)

    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.)

  • Noise

    3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)

    12 months after the CT scan

  • Contrast-related artifact

    3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)

    12 months after the CT scan

  • Overall diagnostic acceptability

    5 points scale qualitative analysis evaluated by two different radiologists (Non-diagnostic, suboptimal, standard, better than standard, Excellent)

    12 months after the CT scan

Study Arms (4)

Chest CT evaluation (Administrate contrast media for CECT)

ACTIVE COMPARATOR

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

Drug: Iohexol (320mgI/mL) with 120kVp

Chest CT evaluation (Experimental 1)

EXPERIMENTAL

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

Drug: Iohexol (320mgI/mL) with 100kVp

Chest CT evaluation (Experimental 2)

EXPERIMENTAL

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

Drug: Iohexol (270mgI/mL) with 100kVp

Chest CT evaluation (Experimental 3)

EXPERIMENTAL

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

Drug: Iohexol (240mgI/mL) with 100kVp

Interventions

Iohexol (320mgI/mL) with 120kVpDRUG

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.

Also known as: Iobrix inj. 320
Chest CT evaluation (Administrate contrast media for CECT)
Iohexol (320mgI/mL) with 100kVpDRUG

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.

Also known as: Iobrix inj. 320
Chest CT evaluation (Experimental 1)
Iohexol (270mgI/mL) with 100kVpDRUG

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.

Also known as: Iobrix inj. 270
Chest CT evaluation (Experimental 2)
Iohexol (240mgI/mL) with 100kVpDRUG

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.

Also known as: Iobrix inj. 240
Chest CT evaluation (Experimental 3)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Bucheon-si, Gyeonggi-do, 14647, South Korea

COMPLETED

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

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

Seoul, Seocho-gu, 06591, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

COMPLETED

Seoul National University Hospital

Seoul, 03080, South Korea

COMPLETED

MeSH Terms

Conditions

Lung Diseases

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Jung Im Jung, MD, PhD

    Seoul St. Mary's Hospital

    STUDY CHAIR

Central Study Contacts

Jung IM Jung, MD, PhD

CONTACT

+822-2258-1456jijung@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 1, 2023

Study Start

November 24, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(6)