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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212882
• Other study ID #: KY23055
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Wuxi People's Hospital
• Contact: Xiangming Fang, Doctor
• Phone: +86 15295557003
• Email: mengxp0711[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: June 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Diagnostic Test:
• Lower concentration and lower volume contrast agent group
CT images using lower concentration and lower volume contrast material

Locations

Country	Name	City	State
China	Wuxi People's Hospital	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Wuxi People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	image quality evaluation of the CTPA images of 30% participants	the mean CT number (in Hounsfield units) in the main pulmonary artery by using a region of interest of at least 1 square centimeter.; 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.; the images quality score for making a diagnosis other than PE ( using a five-point scale ranging from 1 to 5).	through the CTPA examinations of 30% participants finished,, an average of six month
Secondary	overall diagnostic performance for pulmonary embolism	diagnostic accuracy, sensitivity and specificity	CTPA examinations all participants are finished, an average of two month