Chest CT Using Low-concentration Iodine Contrast Media

Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967117
• Other study ID #: CTC42M014
• Status: Recruiting
• Phase: Phase 4
• Start date: November 24, 2023
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Seoul St. Mary's Hospital
• Contact: Jung IM Jung, MD, PhD
• Phone: +822-2258-1456
• Email: jijung[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St. Mary's Hospital, The Catholic University of Korea	Bucheon	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Jeonbuk National University Hospital	Jeonju	Jeollabuk-do
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul	Seocho-gu
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do

Sponsors (2)

Lead Sponsor	Collaborator
Jung Im Jung	Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)
Primary	Noise	3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)	12 months after the CT scan
Primary	Contrast-related artifact	3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)	12 months after the CT scan
Primary	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