Chest CT Using Low-concentration Iodine Contrast Media

NCT ID: NCT05967117

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-24
• Study Completion Date: 2024-11-30

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.

Conditions

Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Iohexol (320mgI/mL) with 120kVp

Intervention Type: DRUG

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.

Chest CT evaluation (Experimental 1)

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

Group Type: EXPERIMENTAL

Iohexol (320mgI/mL) with 100kVp

Intervention Type: DRUG

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.

Chest CT evaluation (Experimental 2)

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

Group Type: EXPERIMENTAL

Iohexol (270mgI/mL) with 100kVp

Intervention Type: DRUG

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.

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)

Group Type: EXPERIMENTAL

Iohexol (240mgI/mL) with 100kVp

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Iobrix inj. 320; Iobrix inj. 320; Iobrix inj. 270; Iobrix inj. 240

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

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taejoon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jung Im Jung

OTHER

Sponsor Role: lead

Responsible Party

Jung Im Jung

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jung Im Jung, MD, PhD

Role: STUDY_CHAIR

Seoul St. Mary's Hospital

Locations

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

Bucheon-si, Gyeonggi-do, South Korea

Site Status: COMPLETED

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status: RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status: RECRUITING

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

Seoul, Seocho-gu, South Korea

Site Status: RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status: COMPLETED

Seoul National University Hospital

Seoul, , South Korea

Site Status: COMPLETED

Countries

South Korea

Central Contacts

Jung IM Jung, MD, PhD

Role: CONTACT

jijung@catholic.ac.kr

+822-2258-1456

Facility Contacts

Department of Radiology

Role: primary

+8263-259-3147

Department of Radiology

Role: primary

+8263-250-2307

Department of Radiology

Role: primary

+822-2258-1456

Other Identifiers

CTC42M014

Identifier Type: -

Identifier Source: org_study_id