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

NCT03415997 | Completed Phase 4 FDA Drug

• 1 other identifier: NSHA REB 1023119
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast Media Dosing

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Secondary Outcomes (1)

• 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)

  1 hour

Study Arms (2)

Total Body Weight

ACTIVE COMPARATOR

Drug: Iohexol

Lean Body Weight

ACTIVE COMPARATOR

Drug: Iohexol

Interventions

Iohexol DRUG

Iodinated contrast media

Lean Body Weight; Total Body Weight

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (1)

• 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.

  PMID: 31439467 DERIVED

MeSH Terms

Interventions

Iohexol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Andreu Costa, Md FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Section Head of Abdominal Radiology, Queen Elizabeth II Health Sciences Centre; Assistant Professor, Dalhousie University

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 30, 2018
• Study Start: February 21, 2018
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CA (1)