search
Back to results

Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight

Primary Purpose

Contrast Media Dosing

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Iohexol
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Contrast Media Dosing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • outpatients only
  • patients scanned on modern Siemens scanners at our institution

Exclusion Criteria:

  • self-reported history of chronic kidney, heart or liver disease
  • allergy to iodinated contrast
  • acute illness
  • outside maximum threshold limit for weight-based contrast dosing
  • pregnancy
  • image degradation

Sites / Locations

  • Queen Elizabeth II Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Total Body Weight

Lean Body Weight

Arm Description

Outcomes

Primary Outcome Measures

Mean hepatic enhancement (MHE): difference in liver attenuation on computed tomography images acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)
Images of the liver will be obtained before and after administration of iodinated contrast media. Regions of interest will be drawn on these pre- and post- contrast computed tomography (CT) images of the liver. The average attenuation before and after contrast administration will be calculated. The mean hepatic enhancement (MHE) will be calculated as the average attenuation post-contrast minus the average attenuation pre-contrast. This will provide a measure of liver enhancement.

Secondary Outcome Measures

Standard deviation in mean hepatic enhancement (sigma MHE): standard deviation in the difference in liver attenuation on CT acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)
Images of the liver will be obtained before and after administration of iodinated contrast media. Regions of interest will be drawn on these pre- and post- contrast computed tomography images of the liver. The average attenuation before and after contrast administration will be calculated. The mean hepatic enhancement (MHE) will be calculated as the average attenuation post-contrast minus the average attenuation pre-contrast. The standard deviation in MHE will provide a measure of inter-patient variability.

Full Information

First Posted
January 18, 2018
Last Updated
January 29, 2019
Sponsor
Nova Scotia Health Authority
search

1. Study Identification

Unique Protocol Identification Number
NCT03415997
Brief Title
Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight
Official Title
Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight at Abdominal CT: a North American Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of dosing iodinated contrast media according to a patient's total body weight vs. lean body weight. Participants will be randomized into 2 groups based on contrast dosing technique, and solid organ enhancement at uniphasic abdominal CT will be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Media Dosing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total Body Weight
Arm Type
Active Comparator
Arm Title
Lean Body Weight
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Iohexol
Intervention Description
Iodinated contrast media
Primary Outcome Measure Information:
Title
Mean hepatic enhancement (MHE): difference in liver attenuation on computed tomography images acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)
Description
Images of the liver will be obtained before and after administration of iodinated contrast media. Regions of interest will be drawn on these pre- and post- contrast computed tomography (CT) images of the liver. The average attenuation before and after contrast administration will be calculated. The mean hepatic enhancement (MHE) will be calculated as the average attenuation post-contrast minus the average attenuation pre-contrast. This will provide a measure of liver enhancement.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Standard deviation in mean hepatic enhancement (sigma MHE): standard deviation in the difference in liver attenuation on CT acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)
Description
Images of the liver will be obtained before and after administration of iodinated contrast media. Regions of interest will be drawn on these pre- and post- contrast computed tomography images of the liver. The average attenuation before and after contrast administration will be calculated. The mean hepatic enhancement (MHE) will be calculated as the average attenuation post-contrast minus the average attenuation pre-contrast. The standard deviation in MHE will provide a measure of inter-patient variability.
Time Frame
1 hour

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: outpatients only patients scanned on modern Siemens scanners at our institution Exclusion Criteria: self-reported history of chronic kidney, heart or liver disease allergy to iodinated contrast acute illness outside maximum threshold limit for weight-based contrast dosing pregnancy image degradation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreu Costa, Md FRCPC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31439467
Citation
Costa AF, Peet K, Abdolell M. Dosing Iodinated Contrast Media According to Lean Versus Total Body Weight at Abdominal CT: A Stratified Randomized Controlled Trial. Acad Radiol. 2020 Jun;27(6):833-840. doi: 10.1016/j.acra.2019.07.014. Epub 2019 Aug 19.
Results Reference
derived

Learn more about this trial

Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight

We'll reach out to this number within 24 hrs