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NCT Number: NCT05967117

Chest CT Using Low-concentration Iodine Contrast Media

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.

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iohexol (320mgI/mL) with 120kVp

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.

Other names: Iobrix inj. 320

Iohexol (320mgI/mL) with 100kVp

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.

Other names: Iobrix inj. 320

Iohexol (270mgI/mL) with 100kVp

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.

Other names: Iobrix inj. 270

Iohexol (240mgI/mL) with 100kVp

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.

Other names: Iobrix inj. 240

Primary outcomes

  1. Anatomic depiction (including image sharpness)

    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.)

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

  2. Noise

    Time frame: 12 months after the CT scan

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

  3. Contrast-related artifact

    Time frame: 12 months after the CT scan

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

  4. Overall diagnostic acceptability

    Time frame: 12 months after the CT scan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jung IM Jung, MD, PhD

CONTACT

[email protected]

+822-2258-1456

Sponsors and collaborators

Lead sponsor

Jung Im Jung

Other

Collaborators

  • Taejoon Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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