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

Recruiting

• Conditions: Pulmonary Embolism
• Interventions: Diagnostic Test: Lower concentration and lower volume contrast agent group

• Registration Number: NCT06212882
• Lead Sponsor: Wuxi People's Hospital

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.

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-12-18
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-11
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lower concentration and lower volume contrast agent group	Lower concentration and lower volume contrast agent group	-
Lower concentration and normal volume contrast agent group	Lower concentration and lower volume contrast agent group	-

Primary Outcome Measures

Name	Time	Method
image quality evaluation of the CTPA images of 30% participants	through the CTPA examinations of 30% participants finished,, an average of six month	1. 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 Outcome Measures

Name	Time	Method
overall diagnostic performance for pulmonary embolism	CTPA examinations all participants are finished, an average of two month	diagnostic accuracy, sensitivity and specificity

Trial Locations

Locations (1)

Wuxi People's Hospital; 🇨🇳 Wuxi, Jiangsu, China