Chest CT Using Low-concentration Iodine Contrast Media

Chest CT Using Low-concentration Iodine Contrast Media - a Prospective Multicenter Comparative Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease
• Intervention / Treatment: Drug: Iohexol (320mgI/mL) with 120kVp; Drug: Iohexol (320mgI/mL) with 100kVp; Drug: Iohexol (270mgI/mL) with 100kVp; Drug: Iohexol (240mgI/mL) with 100kVp

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.

• Study Type: Interventional
• Enrollment (Estimated): 370
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jung IM Jung, MD, PhD; Phone Number: +822-2258-1456; Email: jijung@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of, 61469
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Department of Radiology; Phone Number: +8262-220-5747
    • Principal Investigator: Yun Hyeon Kim, MD, PhD
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Department of Radiology; Phone Number: +822-2072-4920
    • Principal Investigator: Jin Mo Goo, MD, PhD
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 14647
      • Recruiting
      • Bucheon St. Mary's Hospital, The Catholic University of Korea
      • Contact: Department of Radiology; Phone Number: +8232-340-2205
      • Principal Investigator: Bomi Gil, MD, PhD
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
      • Recruiting
      • Pusan National University Yangsan Hospital
      • Contact: Department of Radiology; Phone Number: +8263-259-3147
      • Principal Investigator: YeonJoo Jeong, MD, PhD
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Recruiting
      • Jeonbuk National University Hospital
      • Contact: Department of Radiology; Phone Number: +8263-250-2307
      • Principal Investigator: Gong Yong Jin, MD, PhD
  • Seocho-gu
    • Seoul, Seocho-gu, Korea, Republic of, 06591
      • Recruiting
      • Seoul St. Mary's Hospital, The Catholic University of Korea
      • Contact: Department of Radiology; Phone Number: +822-2258-1456
      • Principal Investigator: Jung Im Jung, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

1. Under the age of 18
2. Cases where contrast-enhanced CT cannot be performed
3. Heart failure
4. Pregnancy
5. If patients cannot voluntarily give written consent to participate in this clinical trial
6. In the case of an anatomical deformation that may interfere with image analysis in the previous image
7. Patients with a history of hypersensitivity to IOBRIX, components of IOBRIX, and iodine-based drugs
8. Patients with severe thyroid disease (Iodine may accumulate in the thyroid gland and worsen symptoms.)
9. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chest CT evaluation (Administrate contrast media for CECT); 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; 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.; Other Names: Iobrix inj. 320
Experimental: Chest CT evaluation (Experimental 1); 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; 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.; Other Names: Iobrix inj. 320
Experimental: Chest CT evaluation (Experimental 2); 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; 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.; Other Names: Iobrix inj. 270
Experimental: Chest CT evaluation (Experimental 3); 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; 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.; Other Names: Iobrix inj. 240

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jung Im Jung
• Collaborators: Taejoon Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Jung Im Jung, MD, PhD, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: CTC42M014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No