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Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Low iodine Spectral Detector CT Pulmonary Angiography
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, Spectral Detector CT, Contrast medium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of contrast dose (as calculated with the OmniVis calculator).
  • Patients with clinical suspicion of disease of PE
  • Referral to CTPA diagnosis, treatment planning or follow-up.
  • Peripheral venous catheter (PVC) =/< 18 G

Exclusion Criteria:

  • Contraindication to iodinated contrast medium
  • Age < 18 years
  • Lack of informed consent
  • Pregnancy

Sites / Locations

  • Akershus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low concentration

Low volume

Saline Dilution

Arm Description

Patients receive a contrast medium with an iodine concentration of 140 mg/ml. The volume is 1 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 90 ml i.e. 12.6 g of iodine.

Patients receive a contrast medium with an iodine concentration 350 of mg/ml. The volume is 0.4 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 36 ml i.e. 12.6 g of iodine.

Patients receive a contrast medium with an iodine concentration of 350 mg/ml. The contrast medium is diluted 1:1 with saline. The injected volume is 0.8 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 72 ml i.e. 12.6 g of iodine.

Outcomes

Primary Outcome Measures

Contrast enhancement (Vascular attenuation)
Contrast enhancement measured as attenuation in the pulmonary artery Branches on the acquired CTPA examination

Secondary Outcome Measures

Homogeneity of contrast enhancement (image noise)
Homogeneity of contrast enhancement is measured as the standard deviation of attenuation in the pulmonary artery branches (equals image noise).
Contrast to noise ratio (CNR)
CNR is measured as (Vascular attenuation - Muscular attenuation) / Image noise
Signal to noise ratio (SNR)
SNR is measured as Vascular attenuation / Image noise

Full Information

First Posted
October 20, 2022
Last Updated
November 24, 2022
Sponsor
University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT05592444
Brief Title
Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography
Official Title
Different Strategies to Reduce Contrast Medium in Computed Tomography Pulmonary Angiography Using Spectral Detector CT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA). 330 patients referred for CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. Effects on the level and homogeneity of contrast enhancement are measured and compared between groups.
Detailed Description
Spectral detector CT facilitates large reductions in contrast medium in vascular CT examinations. To our knowledge, no studies have so far compared different strategies to inject this reduced contrast dose. The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA). 330 patients referred for clinically indicated CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. All patients receive the same amount of iodine (140 mg/kg). Effects on the level and homogeneity of contrast enhancement, image noise, contrast-to-noise-ratio and signal-to-noise-ratio are measured in the CT images and the results are compared between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary Embolism, Spectral Detector CT, Contrast medium

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomly assigned to one of three injection methods: low concentration, low-volume and saline-dilution.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Acquired CT images are identical for all participants. The study arm is unknown to all, except the radiographers (radiology technicians) performing the examination.
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low concentration
Arm Type
Experimental
Arm Description
Patients receive a contrast medium with an iodine concentration of 140 mg/ml. The volume is 1 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 90 ml i.e. 12.6 g of iodine.
Arm Title
Low volume
Arm Type
Experimental
Arm Description
Patients receive a contrast medium with an iodine concentration 350 of mg/ml. The volume is 0.4 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 36 ml i.e. 12.6 g of iodine.
Arm Title
Saline Dilution
Arm Type
Experimental
Arm Description
Patients receive a contrast medium with an iodine concentration of 350 mg/ml. The contrast medium is diluted 1:1 with saline. The injected volume is 0.8 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 72 ml i.e. 12.6 g of iodine.
Intervention Type
Diagnostic Test
Intervention Name(s)
Low iodine Spectral Detector CT Pulmonary Angiography
Intervention Description
Low iodine Spectral Detector CT Pulmonary Angiography
Primary Outcome Measure Information:
Title
Contrast enhancement (Vascular attenuation)
Description
Contrast enhancement measured as attenuation in the pulmonary artery Branches on the acquired CTPA examination
Time Frame
Measured on the CT images from the examination performed at enrollment
Secondary Outcome Measure Information:
Title
Homogeneity of contrast enhancement (image noise)
Description
Homogeneity of contrast enhancement is measured as the standard deviation of attenuation in the pulmonary artery branches (equals image noise).
Time Frame
Measured on the CT images from the examination performed at enrollment
Title
Contrast to noise ratio (CNR)
Description
CNR is measured as (Vascular attenuation - Muscular attenuation) / Image noise
Time Frame
Measured on the CT images from the examination performed at enrollment
Title
Signal to noise ratio (SNR)
Description
SNR is measured as Vascular attenuation / Image noise
Time Frame
Measured on the CT images from the examination performed at enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of contrast dose (as calculated with the OmniVis calculator). Patients with clinical suspicion of disease of PE Referral to CTPA diagnosis, treatment planning or follow-up. Peripheral venous catheter (PVC) =/< 18 G Exclusion Criteria: Contraindication to iodinated contrast medium Age < 18 years Lack of informed consent Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Lauritzen, PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
State/Province
Viken
ZIP/Postal Code
1478
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

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