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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06212882
Enrollment
2100
Registered
2024-01-19
Start date
2023-09-01
Completion date
2025-06-30
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism, Computed Tomography, contrast materials

Brief 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.

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, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; B: 50mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; C: 50mL Ioversol (Ioversol 350, Hengrui, Jiansun, 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.

Interventions

DIAGNOSTIC_TESTLower concentration and lower volume contrast agent group

CT images using lower concentration and lower volume contrast material

Sponsors

Wuxi People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Age greater than 18 years old * Clinical suspicion of pulmonary embolism suggests CTPA examination (Wells score\>4 or D-2 polymer elevation) * Patient's general physical condition tolerates CTPA examination

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
image quality evaluation of the CTPA images of 30% participantsthrough the CTPA examinations of 30% participants finished,, an average of six month1. the mean CT number (in Hounsfield units) in the main pulmonary artery by using a region of interest of at least 1 square centimeter. 2. the CT number (in Hounsfield units) of peripheral pulmonary arteries close to the beginning and the end of each scan in a egmental or subsegmental artery at an apical and a basal section position. Because the caliber of the peripheral vessels was too small to reliably set an intraluminal region of interest to determine the mean CT number, the maximum CT number as a proxy for vascular attenuation should be chosen. 3. the images quality score for making a diagnosis other than PE ( using a five-point scale ranging from 1 to 5).

Secondary

MeasureTime frameDescription
overall diagnostic performance for pulmonary embolismCTPA examinations all participants are finished, an average of two monthdiagnostic accuracy, sensitivity and specificity

Countries

China

Contacts

Primary ContactXiangming Fang, Doctor
mengxp0711@163.com+86 15295557003

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026