Iodine Mapping Using Subtraction in Pulmonary Embolism CT Versus Dual-Energy CT (InSPECT-DECT)

November 6, 2017 updated by: Radboud University Medical Center

Iodine Mapping Using Subtraction in Pulmonary Embolism Computed Tomography Versus Dual Energy Computed Tomography

Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for patients with suspected with pulmonary embolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: Iodine mapping of the lung using subtraction imaging in addition to standard computed tomography pulmonary angiography (CTPA) may improve the evaluation of pulmonary embolism (PE) in the same manner as the addition of dual energy computed tomography (DECT) to CTPA.

Objective: To evaluate image quality and accuracy of detection of perfusion defects associated with pulmonary pathology on iodine maps of the lung that are created by two different CT techniques: 1. A standard of care CTPA with DECT and 2. A new technique that subtracts a low radiation dose unenhanced CT from mono-energetic CTPA (subtraction) Study design: A maximum of 375 patients will undergo a standard CTPA with DECT according to local clinical guidelines, to have 30 patients with pulmonary embolism. For the purposes of this study, patients will undergo an additional unenhanced, low-radiation dose chest CT. Standard reconstructions of all scans and DECT iodine maps will be obtained for clinical reporting and subsequent treatment decisions, according to standard clinical routine. For research purposes, selected mono-energetic images will be post-processed using a novel subtraction algorithm to create iodine maps of the lungs. The iodine maps based on the subtraction algorithm will not be used for clinical management, only the additional unenhanced scan will be used in clinical management.

Study population: Patients presenting with a clinical indication for pulmonary CT angiography because of suspected pulmonary embolism. Only adult patients (≥ 35 years) who are able to provide informed consent will be enrolled.

Main study parameters/endpoints:

Main endpoint of the study is presence of perfusion as established by an expert panel with access to all imaging information (including CTPA, subtraction and DECT) and clinical follow-up. Accuracy of DECT and subtraction is established by observers who are blinded to CTPA and clinical data. Presence of iodine density differences in perfusion defects is measured using region of interest (ROI) measurements.

Images will be evaluated for objective and subjective image quality. Patient characteristics, radiation dose, clinical diagnosis, treatment decisions and patient outcome (all cause - and PE related mortality) will be recorded.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

CT imaging is associated with risks related to the use of radiation and iodinated contrast administration. No additional contrast will be used as compared to standard clinical practice as patients will only undergo one CTPA scan. The CT protocol of this study has been carefully designed to have a radiation dose identical or even lower than standard CT protocols for pulmonary embolism detection. The estimated dose-length product (DLP) of standard CTPA with DECT in Meander Medical Centre is 167 mGy-cm (effective dose is 2.4 mSv, using 0,0146 mSv/mGy-cm as a conversion factor). The researchers will expose patients who participate in the study to an estimated additional DLP of 72 mGy-cm due to the unenhanced scan, resulting in an additional estimated effective dose of 1,0 mSv. This implies that the total radiation dose is within the same range as radiation doses of other scans for PE detection in the Netherlands. The additional scan is not obligatory in pulmonary embolism diagnosis, but will be used for clinical evaluation of these patients.

Study Type

Interventional

Enrollment (Actual)

295

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500
        • Radboudumc

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

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 35 years or older and able to provide informed consent
  • Clinically requested CTPA because of suspected pulmonary embolism
  • Available history and physical examination.

Exclusion Criteria:

  • Pregnancy
  • Hemodynamic instability
  • Uncooperative patients.
  • Contra-indication to intravenous iodine administration.
  • Inability to position the arms above the shoulders

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients
Each patient undergo the same CT protocol. Theobservers will observe the detection of the perfusion defects in two different techniques.
Device: Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography
Compare two techniques of the CT scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of perfusion defects as reference standard
Time Frame: 1.5 year
After 1.5 year, the radiologists scores the presence of perfusion defects caused by pulmonary embolism as a reference standard.
1.5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiation dose
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months
Clinical diagnosis of Pulmonary embolism: after 6 months follow-up
Time Frame: Through study completion, after the first inclusion, the patients are followed for half a year.
Through study completion, after the first inclusion, the patients are followed for half a year.
30-day all cause mortality and PE-associated mortality
Time Frame: Through study completion, an average of three months
Through study completion, an average of three months
6 months all cause mortality and PE-associated mortality
Time Frame: Through study completion, an average of three months
Through study completion, an average of three months

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Study Chair: Monique Brink, MD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 7, 2016

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL56542.091.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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