Pulmonary EmbolismNCT06212882

Optimization of DE-CTPA Images and Diagnostic Pathway: Using Low Concentration Iodine Contrast Material

A study testing DE-CTPA with 30 mL iomeprol 300 mg I/mL, DE-CTPA with 50 mL iomeprol 300 mg I/mL and DE-CTPA with 50 mL Ioversol 350 mg I/mL in people with Pulmonary Embolism, run by Wuxi People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators aimed to compare the image quality and diagnostic performance of DECTPA using lower concentration iodine contrast materials and using normal concentration iodine contrast materials in the evaluation of suspected pulmonary embolism. Read more about this study

Who is it for?: Ages 18 to 97 years
Conditions the study is for: Pulmonary Embolism
What is being tested?: DE-CTPA with 30 mL iomeprol 300 mg I/mL, DE-CTPA with 50 mL iomeprol 300 mg I/mL and DE-CTPA with 50 mL Ioversol 350 mg I/mL
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,216 participants
Where: 1 siteChina
Study dates: 28 Sep 2023to 30 Jun 2026
Phase: Interventional
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 18 to 97 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years old
Clinical suspicion of pulmonary embolism suggests CTPA examination (Wells score>4 or age-adjusted D-dimer elevation)
Patient's general physical condition tolerates CTPA examination

Who cannot join

Allergy to iodine contrast agents
Hyperthyroidism
Pregnancy
Weight greater than 80kg
Heart failure patients, NYHA heart function level III or IV

Trial locations and contacts

1 site in 1 country.

China1 site

Wuxi People's Hospital
Wuxi, Jiangsu, 214043

Other trials in China

About this study

Official title: Dual Energy CT Angiography in Suspected Pulmonary Embolism: Influence of Concentration of Contrast Materials on Image Quality and Diagnostic Performance

Read the detailed description

All patients met the inclusion and exclusion criteria will be given written informed consensus. The enrolled patients will randomly receive one of the three injection protocols: A: 30mL Iomeprol (Iomeron, 300 mg I/mL; Bracco Imaging Italia S.r.l., Milan, Italy) injected at a flow rate of 4mL/s; B: 50mL Iomeprol (Iomeron, 300 mg I/mL; Bracco Imaging Italia S.r.l., Milan, Italy) injected at a flow rate of 4mL/s; C: 50mL Ioversol (Ioversol, 350mg I/mL, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Jiangsu, China) injected at a flow rate of 4mL/s. A and B groups are both lower concentration iodine contrast material groups, with different total iodine loads.

Conditions: Pulmonary Embolism
Being tested: DE-CTPA with 30 mL iomeprol 300 mg I/mL, DE-CTPA with 50 mL iomeprol 300 mg I/mL, DE-CTPA with 50 mL Ioversol 350 mg I/mL
Keywords: pulmonary embolism, Computed Tomography, contrast materials
Medical subject headings: Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DE-CTPA with 30 mL iomeprol 300 mg I/mLDiagnostic test
Dual-energy CTPA was performed after intravenous administration of 30 mL of iomeprol (300 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.
DE-CTPA with 50 mL iomeprol 300 mg I/mLDiagnostic test
Dual-energy CTPA was performed after intravenous administration of 50 mL of iomeprol (300 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.
DE-CTPA with 50 mL Ioversol 350 mg I/mLDiagnostic test
Dual-energy CTPA was performed after intravenous administration of 50 mL of Ioversol (350 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.

Study groups in NCT06212882
Study group	Role	What they receive
Protocol A: 30 mL iomeprol 300 mg I/mL	Experimental	Participants received 30 mL of iomeprol (300 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser. Receives: Diagnostic Test: DE-CTPA with 30 mL iomeprol 300 mg I/mL
Protocol B: 50 mL iomeprol 300 mg I/mL	Experimental	Participants received 50 mL of iomeprol (300 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser. Receives: Diagnostic Test: DE-CTPA with 50 mL iomeprol 300 mg I/mL
Protocol C: 50 mL Ioversol 350 mg I/mL	Active comparator	Participants received 50 mL of Ioversol (350 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser. Receives: Diagnostic Test: DE-CTPA with 50 mL Ioversol 350 mg I/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

Pulmonary arterial attenuation on CTPA
Pulmonary arterial attenuation was measured in Hounsfield units (HU) at predefined pulmonary arterial levels.
Measured: Baseline (during the CTPA examination)
Image noise on CTPA
Image noise was quantified as the standard deviation of CT attenuation values within predefined regions of interest, expressed in Hounsfield units (HU).
Measured: Baseline (during the CTPA examination)
Signal-to-noise ratio (SNR) on CTPA
The signal-to-noise ratio (SNR) was calculated as the mean vascular attenuation divided by image noise. SNR is a dimensionless measure.
Measured: Baseline (during the CTPA examination)
Contrast-to-noise ratio (CNR) on CTPA
The contrast-to-noise ratio (CNR) was calculated as the difference in mean CT attenuation between the pulmonary artery and reference tissue divided by image noise. CNR is a dimensionless measure.
Measured: Baseline (during the CTPA examination)
Subjective image quality score on CTPA
Diagnostic image quality was assessed using a 5-point ordinal scale, ranging from 1 (poorest image quality) to 5 (best image quality), with higher scores indicating better image quality.
Measured: Baseline (during the CTPA examination)

Secondary outcomes (6)

Diagnostic accuracy of CTPA for pulmonary embolism
Diagnostic accuracy was calculated as the proportion of correctly classified cases (true positives and true negatives) among all evaluable cases, using the reference standard for pulmonary embolism diagnosis. Results were expressed as percentages (%).
Measured: Baseline (during the CTPA examination)
Sensitivity of CTPA for pulmonary embolism
Sensitivity was calculated as the proportion of true-positive cases among all cases with pulmonary embolism confirmed by the reference standard. Results were expressed as percentages (%).
Measured: Baseline (during the CTPA examination)
Specificity of CTPA for pulmonary embolism
Specificity was calculated as the proportion of true-negative cases among all cases without pulmonary embolism according to the reference standard. Results were expressed as percentages (%).
Measured: Baseline (during the CTPA examination)
Diagnostic accuracy for isolated SSPE
Diagnostic accuracy was calculated as the proportion of correctly classified cases (true positives and true negatives) among all evaluable cases, using the reference standard for isolated subsegmental pulmonary embolism (SSPE). Results were expressed as percentages (%).
Measured: Baseline (during the CTPA examination)
Sensitivity of CTPA for isolated subsegmental pulmonary embolism
Sensitivity was calculated as the proportion of true-positive cases among all cases with isolated subsegmental pulmonary embolism (SSPE) confirmed by the reference standard. Results were expressed as percentages (%).
Measured: Baseline (during the CTPA examination)
Specificity of CTPA for isolated subsegmental pulmonary embolism
Specificity was calculated as the proportion of true-negative cases among all cases without isolated subsegmental pulmonary embolism (SSPE) according to the reference standard. Results were expressed as percentages (%).
Measured: Baseline (during the CTPA examination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 202330 Jun 2026

First posted19 Jan 2024
Study start28 Sep 2023
Primary completion31 Dec 2025
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary EmbolismStudies 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 N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Participants were assigned to one of three parallel contrast administration protocols. Randomized allocation was used at nine participating centers, whereas protocol assignment at the remaining centers was based on prespecified time periods. Each participant received only one contrast protocol.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 2,216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06212882
Sponsor's protocol ID: KY23055
Status last verified: Oct 2026
First submitted: 18 Dec 2023
Last updated: 29 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Embolism trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dual Energy CT Angiography in Suspected Pulmonary Embolism: Influence of Concentration of Contrast Materials on Image Quality and Diagnostic Performance
ClinicalTrials.gov ID: NCT06212882
Acronym / sponsor ID: KY23055
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism, Computed Tomography, contrast materials
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,216 participants (actual)
Lead sponsor: Wuxi People's HospitalUniversity, hospital or other
Study start: 28 Sep 2023 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 19 Jan 2024 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Participants were assigned to one of three parallel contrast administration protocols. Randomized allocation was used at nine participating centers, whereas protocol assignment at the remaining centers was based on prespecified time periods. Each participant received only one contrast protocol.

Arm	Type	Receives
Protocol A: 30 mL iomeprol 300 mg I/mL	Experimental	Diagnostic Test: DE-CTPA with 30 mL iomeprol 300 mg I/mLParticipants received 30 mL of iomeprol (300 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.
Protocol B: 50 mL iomeprol 300 mg I/mL	Experimental	Diagnostic Test: DE-CTPA with 50 mL iomeprol 300 mg I/mLParticipants received 50 mL of iomeprol (300 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.
Protocol C: 50 mL Ioversol 350 mg I/mL	Active comparator	Diagnostic Test: DE-CTPA with 50 mL Ioversol 350 mg I/mLParticipants received 50 mL of Ioversol (350 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.

Who may qualify

Ages: 18 to 97 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥18 years old
Clinical suspicion of pulmonary embolism suggests CTPA examination (Wells score>4 or age-adjusted D-dimer elevation)
Patient's general physical condition tolerates CTPA examination

Key exclusion criteria (5 listed)

Allergy to iodine contrast agents
Hyperthyroidism
Pregnancy
Weight greater than 80kg
Heart failure patients, NYHA heart function level III or IV

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
DE-CTPA with 30 mL iomeprol 300 mg I/mLDual-energy CTPA was performed after intravenous administration of 30 mL of iomeprol (300 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.	Diagnostic test	Protocol A: 30 mL iomeprol 300 mg I/mL
DE-CTPA with 50 mL iomeprol 300 mg I/mLDual-energy CTPA was performed after intravenous administration of 50 mL of iomeprol (300 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.	Diagnostic test	Protocol B: 50 mL iomeprol 300 mg I/mL
DE-CTPA with 50 mL Ioversol 350 mg I/mLDual-energy CTPA was performed after intravenous administration of 50 mL of Ioversol (350 mg I/mL) at an injection rate of 4.0 mL/s, followed by a 30-mL saline chaser.	Diagnostic test	Protocol C: 50 mL Ioversol 350 mg I/mL

Primary outcome

Pulmonary arterial attenuation on CTPA
Time frame: Baseline (during the CTPA examination)
Pulmonary arterial attenuation was measured in Hounsfield units (HU) at predefined pulmonary arterial levels.
Image noise on CTPA
Time frame: Baseline (during the CTPA examination)
Image noise was quantified as the standard deviation of CT attenuation values within predefined regions of interest, expressed in Hounsfield units (HU).
Signal-to-noise ratio (SNR) on CTPA
Time frame: Baseline (during the CTPA examination)
The signal-to-noise ratio (SNR) was calculated as the mean vascular attenuation divided by image noise. SNR is a dimensionless measure.
Contrast-to-noise ratio (CNR) on CTPA
Time frame: Baseline (during the CTPA examination)
The contrast-to-noise ratio (CNR) was calculated as the difference in mean CT attenuation between the pulmonary artery and reference tissue divided by image noise. CNR is a dimensionless measure.
Subjective image quality score on CTPA
Time frame: Baseline (during the CTPA examination)
Diagnostic image quality was assessed using a 5-point ordinal scale, ranging from 1 (poorest image quality) to 5 (best image quality), with higher scores indicating better image quality.

6 secondary outcomes

Diagnostic accuracy of CTPA for pulmonary embolism
Time frame: Baseline (during the CTPA examination)
Sensitivity of CTPA for pulmonary embolism
Time frame: Baseline (during the CTPA examination)
Specificity of CTPA for pulmonary embolism
Time frame: Baseline (during the CTPA examination)
Diagnostic accuracy for isolated SSPE
Time frame: Baseline (during the CTPA examination)
Sensitivity of CTPA for isolated subsegmental pulmonary embolism
Time frame: Baseline (during the CTPA examination)
Specificity of CTPA for isolated subsegmental pulmonary embolism
Time frame: Baseline (during the CTPA examination)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Pulmonary Embolism

RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingObservational study
Inari VISION Registry
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Not yet recruitingPhase 3
Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary arterial attenuation on CTPA (time frame: Baseline (during the CTPA examination)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06212882.

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 29 Oct 2026.