ClinicalTrials.gg
CompletedNCT06212882Updated Oct 29, 2026

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

An interventional study of DE-CTPA with 30 mL iomeprol 300 mg I/mL and DE-CTPA with 50 mL iomeprol 300 mg I/mL in Pulmonary Embolism, sponsored by Wuxi People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 97 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Wuxi People's Hospital · Not applicable, Interventional, and Diagnostic

Updated Oct 29, 2026Now CompletedStart date moved+7 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
2,216
Allocation
Non-randomized
Ages
18 Years to 97 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 72 studies in Pulmonary Embolism with a site in China — 26 open to participants now, 31 under way, 1 of them phase 3. Pulmonary Embolism · China.

Enrollment
10th of 33
2,216 · median 417
Started
2023
with 4 others
No phase
14 of 72
5 open now
Registered
50th of 72
by date

Among the 72 studies in Pulmonary Embolism with a site in China, this one is the 10th largest by enrollment of the 33 interventional ones, is one of 5 that started in 2023, is one of 14 with no phase, and was the 50th registered.

By phase

72 studies; the count open now beside each. This study's row is marked.

Observational39 · 20 open
No phasethis study14 · 5 open
Phase 311 · 1 open
Phase 47 · 0 open
Phase 21 · 0 open

By the year they started

First in 2002; this study’s year is marked. 5 started in 2023.

Size and results

Median enrollment 417 across the 33 interventional studies, 1,000 across the 39 observational. Of the 28 that completed or were terminated, 7 (25%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 72 studies in Pulmonary Embolism with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Pulmonary Embolism

Browse trials for

Keywords

  • pulmonary embolism
  • Computed Tomography
  • contrast materials
04

Who can participate

The criteria were revised on the registry on Oct 29, 2026. See what changed

Ages eligible
18 Years to 97 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Allergy to iodine contrast agents
  • Hyperthyroidism
  • Pregnancy
  • Weight greater than 80kg
  • Heart failure patients, heart function level III or IV
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2,216 participants (actual)

Study arms

  • Experimental
    Protocol A: 30 mL iomeprol 300 mg I/mL

    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.

    Diagnostic Test: DE-CTPA with 30 mL iomeprol 300 mg I/mL

  • Experimental
    Protocol B: 50 mL iomeprol 300 mg I/mL

    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.

    Diagnostic Test: DE-CTPA with 50 mL iomeprol 300 mg I/mL

  • Active comparator
    Protocol C: 50 mL Ioversol 350 mg I/mL

    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.

    Diagnostic Test: DE-CTPA with 50 mL Ioversol 350 mg I/mL

Interventions

  • Diagnostic testDE-CTPA with 30 mL iomeprol 300 mg I/mL

    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.

  • Diagnostic testDE-CTPA with 50 mL iomeprol 300 mg I/mL

    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.

  • Diagnostic testDE-CTPA with 50 mL Ioversol 350 mg I/mL

    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.

06

What researchers measure

Primary outcomes

  1. Pulmonary arterial attenuation on CTPA

    Pulmonary arterial attenuation was measured in Hounsfield units (HU) at predefined pulmonary arterial levels.

    Time frame: Baseline (during the CTPA examination)

  2. 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).

    Time frame: Baseline (during the CTPA examination)

  3. 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.

    Time frame: Baseline (during the CTPA examination)

  4. 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.

    Time frame: Baseline (during the CTPA examination)

  5. 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.

    Time frame: Baseline (during the CTPA examination)

Secondary outcomes

  1. 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 (%).

    Time frame: Baseline (during the CTPA examination)

  2. 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 (%).

    Time frame: Baseline (during the CTPA examination)

  3. 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 (%).

    Time frame: Baseline (during the CTPA examination)

  4. 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 (%).

    Time frame: Baseline (during the CTPA examination)

  5. 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 (%).

    Time frame: Baseline (during the CTPA examination)

  6. 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 (%).

    Time frame: Baseline (during the CTPA examination)

07

Study locations

1 site
  • Wuxi People's Hospital
    Wuxi, Jiangsu 214043, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2023 to primary completion in Dec 2025, 27 months.

Of 125 non-industry interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's 27 months is close to that.

Counting every sponsor, half of 150 studies reached it within 25 months; a quarter within 15 and three quarters within 51.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: primary completion Nov 2024 → Dec 2025 and completion Jun 2025 → Jun 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2023
First posted
Jan 19, 2024
StartActual
Sep 28, 2023
Primary completionActual
Dec 31, 2025was Nov 2024
CompletionActual
Jun 30, 2026was Jun 2025
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 29, 2026
Start date
Sep 1, 2023→Sep 28, 2023
Oct 29, 2026
Primary completion
Nov 2024→Dec 31, 2025 (actual)
Oct 29, 2026
Study completion
Jun 2025→Jun 30, 2026 (actual)
Oct 29, 2026
Enrollment
2100 (estimated)→2216 (actual)
Oct 29, 2026
Eligibility
Maximum age 90 Years→97 Years; 2 inclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedAge greater than ≥18 years old
  • EditedClinical suspicion of pulmonary embolism suggests CTPA examination (Wells score>4 or age-adjusted D-2 polymerdimer elevation)
Oct 29, 2026
Interventions
Added Diagnostic test: DE-CTPA with 30 mL iomeprol 300 mg I/mL·Diagnostic test: DE-CTPA with 50 mL iomeprol 300 mg I/mL·Diagnostic test: DE-CTPA with 50 mL Ioversol 350 mg I/mL; removed Diagnostic test: Lower concentration and lower volume contrast agent group. Arms added: Protocol A: 30 mL iomeprol 300 mg I/mL·Protocol B: 50 mL iomeprol 300 mg I/mL·Protocol C: 50 mL Ioversol 350 mg I/mL; arms removed: Lower concentration and lower volume contrast agent group·Lower concentration and normal volume contrast agent group·Normal concentration and normal volume contrast agent group
Oct 29, 2026
Primary outcomes
5 added, 1 removed
What changed in the outcomes
  • AddedPulmonary arterial attenuation on CTPATime frame: Baseline (during the CTPA examination)
  • AddedImage noise on CTPATime frame: Baseline (during the CTPA examination)
  • AddedSignal-to-noise ratio (SNR) on CTPATime frame: Baseline (during the CTPA examination)
  • AddedContrast-to-noise ratio (CNR) on CTPATime frame: Baseline (during the CTPA examination)
  • AddedSubjective image quality score on CTPATime frame: Baseline (during the CTPA examination)
  • Removedimage quality evaluation of the CTPA images of 30% participantsTime frame: through the CTPA examinations of 30% participants finished,, an average of six month
Oct 29, 2026
Secondary outcomes
1 edited, 5 added
What changed in the outcomes
  • Editedoverall diagnostic performanceDiagnostic accuracy of CTPA for pulmonary embolismTime frame: CTPA examinations all participants are finished, an average of two month → Baseline (during the CTPA examination)
  • AddedSensitivity of CTPA for pulmonary embolismTime frame: Baseline (during the CTPA examination)
  • AddedSpecificity of CTPA for pulmonary embolismTime frame: Baseline (during the CTPA examination)
  • AddedDiagnostic accuracy for isolated SSPETime frame: Baseline (during the CTPA examination)
  • AddedSensitivity of CTPA for isolated subsegmental pulmonary embolismTime frame: Baseline (during the CTPA examination)
  • AddedSpecificity of CTPA for isolated subsegmental pulmonary embolismTime frame: Baseline (during the CTPA examination)
Oct 29, 2026
Design
Study type Observational→Interventional
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Recruiting→Completed
    Start date Sep 1, 2023→Sep 28, 2023
    Primary completion Nov 2024→Dec 31, 2025 (now actual)
    Study completion Jun 2025→Jun 30, 2026 (now actual)
    Enrollment 2100 (estimated)→2216 (actual)
    Eligibility Maximum age 90 Years→97 Years; 2 inclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedAge greater than ≥18 years old
    • EditedClinical suspicion of pulmonary embolism suggests CTPA examination (Wells score>4 or age-adjusted D-2 polymerdimer elevation)
    Primary outcomes 5 added, 1 removed
    What changed in the outcomes
    • AddedPulmonary arterial attenuation on CTPATime frame: Baseline (during the CTPA examination)
    • AddedImage noise on CTPATime frame: Baseline (during the CTPA examination)
    • AddedSignal-to-noise ratio (SNR) on CTPATime frame: Baseline (during the CTPA examination)
    • AddedContrast-to-noise ratio (CNR) on CTPATime frame: Baseline (during the CTPA examination)
    • AddedSubjective image quality score on CTPATime frame: Baseline (during the CTPA examination)
    • Removedimage quality evaluation of the CTPA images of 30% participantsTime frame: through the CTPA examinations of 30% participants finished,, an average of six month
    Secondary outcomes 1 edited, 5 added
    What changed in the outcomes
    • Editedoverall diagnostic performanceDiagnostic accuracy of CTPA for pulmonary embolismTime frame: CTPA examinations all participants are finished, an average of two month → Baseline (during the CTPA examination)
    • AddedSensitivity of CTPA for pulmonary embolismTime frame: Baseline (during the CTPA examination)
    • AddedSpecificity of CTPA for pulmonary embolismTime frame: Baseline (during the CTPA examination)
    • AddedDiagnostic accuracy for isolated SSPETime frame: Baseline (during the CTPA examination)
    • AddedSensitivity of CTPA for isolated subsegmental pulmonary embolismTime frame: Baseline (during the CTPA examination)
    • AddedSpecificity of CTPA for isolated subsegmental pulmonary embolismTime frame: Baseline (during the CTPA examination)
    Interventions Added Diagnostic test: DE-CTPA with 30 mL iomeprol 300 mg I/mL·Diagnostic test: DE-CTPA with 50 mL iomeprol 300 mg I/mL·Diagnostic test: DE-CTPA with 50 mL Ioversol 350 mg I/mL; removed Diagnostic test: Lower concentration and lower volume contrast agent group. Arms added: Protocol A: 30 mL iomeprol 300 mg I/mL·Protocol B: 50 mL iomeprol 300 mg I/mL·Protocol C: 50 mL Ioversol 350 mg I/mL; arms removed: Lower concentration and lower volume contrast agent group·Lower concentration and normal volume contrast agent group·Normal concentration and normal volume contrast agent group
    Design Study type Observational→Interventional
    + 9 other changes: identifiers, verification date, responsible party, oversight details, description, contact details, site details, data sharing statement and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06212882
Lead sponsor
Wuxi People's Hospital
Responsible party
Sponsor
First posted
Jan 19, 2024
Start date
Sep 28, 2023
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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