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

January 18, 2024 updated by: Peihua Lu, Wuxi People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214043
        • Recruiting
        • Wuxi People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients who will undergo CT pulmonary angiography due to clinical suspicion of pulmonary embolism

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lower concentration and lower volume contrast agent group
Diagnostic test: Lower concentration and lower volume contrast agent group
CT images using lower concentration and lower volume contrast material
Lower concentration and normal volume contrast agent group
Diagnostic test: Lower concentration and lower volume contrast agent group
CT images using lower concentration and lower volume contrast material
Normal concentration and normal volume contrast agent group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
image quality evaluation of the CTPA images of 30% participants
Time Frame: 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).
through the CTPA examinations of 30% participants finished,, an average of six month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall diagnostic performance for pulmonary embolism
Time Frame: CTPA examinations all participants are finished, an average of two month
diagnostic accuracy, sensitivity and specificity
CTPA examinations all participants are finished, an average of two month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuxi People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY23055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

index that measuring image quality and pulmonary embolism CTPA diagnostic results for each individual

IPD Sharing Time Frame

After the main paper is published.

IPD Sharing Access Criteria

application from the Central Contact Person

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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