Pulmonary DiseasePhase 4NCT05967117
Chest CT Using Low-concentration Iodine Contrast Media
A Phase 4 study testing Iohexol (320mgI/mL) with 120kVp, Iohexol (320mgI/mL) with 100kVp and Iohexol (270mgI/mL) with 100kVp in people with Pulmonary Disease, run by Jung Im Jung at 6 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Iohexol (320mgI/mL) with 120kVp, Iohexol (320mgI/mL) with 100kVp and Iohexol (270mgI/mL) with 100kVp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 24 Nov 2023to Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 3 recruiting
- Completed
Bucheon St. Mary's Hospital, The Catholic University of Korea
Bucheon-si, Gyeonggi-do, 14647
- Completed
Chonnam National University Hospital
Gwangju, 61469
- Recruiting
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Department of Radiology, +8263-250-2307
Gong Yong Jin, MD, PhD
- Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Seocho-gu, 06591
Department of Radiology, +822-2258-1456
Jung Im Jung, MD, PhD
- Completed
Seoul National University Hospital
Seoul, 03080
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Department of Radiology, +8263-259-3147
YeonJoo Jeong, MD, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Iohexol (320mgI/mL) with 120kVp, Iohexol (320mgI/mL) with 100kVp, Iohexol (270mgI/mL) with 100kVp, Iohexol (240mgI/mL) with 100kVp
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iohexol (320mgI/mL) with 120kVpDrug
Also called Iobrix inj. 320
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 100kVpDrug
Also called Iobrix inj. 320
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 100kVpDrug
Also called Iobrix inj. 270
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 100kVpDrug
Also called Iobrix inj. 240
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.
| Study group | Role | What they receive |
|---|---|---|
| Chest CT evaluation (Administrate contrast media for CECT) | Active comparator | Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the conventional tube voltage Receives: Drug: Iohexol (320mgI/mL) with 120kVp |
| Chest CT evaluation (Experimental 1) | Experimental | Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the low tube voltage Receives: Drug: Iohexol (320mgI/mL) with 100kVp |
| Chest CT evaluation (Experimental 2) | Experimental | Patients who are planned chest contrast enhanced CT scan ; Low concentration iodine contrast agents with the low tube voltage) Receives: Drug: Iohexol (270mgI/mL) with 100kVp |
| Chest CT evaluation (Experimental 3) | Experimental | Patients who are planned chest contrast enhanced CT scan; Ultra Low concentration iodine contrast agents with the low tube voltage) Receives: Drug: Iohexol (240mgI/mL) with 100kVp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic depiction (including image sharpness)
3 points scale qualitative analysis evaluated by two different radiologists (Poor, moderate, excellent)
Measured: 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)
Measured: 12 months after the CT scan
Contrast-related artifact
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
Measured: 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)
Measured: 12 months after the CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start24 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jung Im Jung
- Sponsor type
- University, hospital or other
- Collaborators
- Taejoon Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Jung Im Jung, Seoul St. Mary's Hospital
- Investigators
- Jung Im Jung, MD, PhD, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967117
- Sponsor's protocol ID
- CTC42M014
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest CT Using Low-concentration Iodine Contrast Media - a Prospective Multicenter Comparative Study
- ClinicalTrials.gov ID
- NCT05967117
- Acronym / sponsor ID
- CTC42M014
- Conditions
- Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Jung Im JungUniversity, hospital or other
- Collaborators
- Taejoon Pharmaceutical Co., Ltd.
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chest CT evaluation (Administrate contrast media for CECT) | Active comparator | Drug: Iohexol (320mgI/mL) with 120kVpPatients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the conventional tube voltage |
| Chest CT evaluation (Experimental 1) | Experimental | Drug: Iohexol (320mgI/mL) with 100kVpPatients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the low tube voltage |
| Chest CT evaluation (Experimental 2) | Experimental | Drug: Iohexol (270mgI/mL) with 100kVpPatients who are planned chest contrast enhanced CT scan ; Low concentration iodine contrast agents with the low tube voltage) |
| Chest CT evaluation (Experimental 3) | Experimental | Drug: Iohexol (240mgI/mL) with 100kVpPatients who are planned chest contrast enhanced CT scan; Ultra Low concentration iodine contrast agents with the low tube voltage) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iohexol (320mgI/mL) with 120kVpAlso: Iobrix inj. 320Patient 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. | Drug | Chest CT evaluation (Administrate contrast media for CECT) |
| Iohexol (320mgI/mL) with 100kVpAlso: Iobrix inj. 320Patient 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. | Drug | Chest CT evaluation (Experimental 1) |
| Iohexol (270mgI/mL) with 100kVpAlso: Iobrix inj. 270Patient 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. | Drug | Chest CT evaluation (Experimental 2) |
| Iohexol (240mgI/mL) with 100kVpAlso: Iobrix inj. 240Patient 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. | Drug | Chest CT evaluation (Experimental 3) |
Primary outcome
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)
Noise
Time frame: 12 months after the CT scan
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
Contrast-related artifact
Time frame: 12 months after the CT scan
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Im Jung, MD, PhD study chair
Seoul St. Mary's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iohexol (320mgI/mL) with 120kVp, Iohexol (320mgI/mL) with 100kVp and Iohexol (270mgI/mL) with 100kVp in people with Pulmonary Disease, run by Jung Im Jung at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung IM Jung, MD, PhD (+822-2258-1456, jijung@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.