Health TrialsbyHealthPanel

Chest CT Using Low-concentration Iodine Contrast Media

ConditionPulmonary Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorJung Im Jung

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Under the age of 18

Cases where contrast-enhanced CT cannot be performed

Heart failure

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

370 Participants
are divided into 4 treatment groups
Group A: Chest CT evaluation (Administrate contrast media for CECT)Active comparator 1 intervention
Group B: Chest CT evaluation (Experimental 1)Experimental treatment 1 intervention
Group C: Chest CT evaluation (Experimental 2)Experimental treatment 1 intervention
Group D: Chest CT evaluation (Experimental 3)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anatomic depiction (including image sharpness)

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

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.)
2

Noise

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

Time frame
12 months after the CT scan
3

Contrast-related artifact

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

Time frame
12 months after the CT scan
4

Overall diagnostic acceptability

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

Time frame
12 months after the CT scan

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jung Im Jung

Lead sponsor

Seoul St. Mary's Hospital

Sponsor institution

Taejoon Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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