Improved Chest CT Diagnostic and Contrast Medium Administration

Investigation of impact of using different CM approaches on contrast enhancement in chest Ct examinations - A prospective study

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: Other: Adopted contrast media amount by using different approaches

Detailed Description

Continuing advances in computed tomography (CT) in the past decades such as short scanning times with multi-detector CT (MDCT) requires contrast medium (CM) administration to be precisely planned to ensure a diagnostically accurate CT scans. To improve the chest CT diagnostic, the contrast enhancement in the thoracic vessels shoulde be increased.

The most important patient-related factors affecting the magnitude of vascular and parenchymal contrast enhancement are body weight. Historical practice has been to use a fixed volume of CM independent of body weight. Research has shown a clear relationship between vessel enhancement and patient weight, and that fixed CM volume technique is inappropriate, as smaller patients may receive excessive volume, and larger patients insufficient volume resulting in reduced image quality and poor diagnostic. In addition, excess CM can result in contrast induced adverse effects and nephropathy. To overcome these problems, it is essential to adjust the CM volume to the patient's total body weight and body composition. This adjustment can be done in different ways. The aim of this study is to identify which weight/body tailored CM administration is the best replacement for fixed CM administration in chest CT. The cost and procedure time will also be explored.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Safora F Johansen, PhD; Phone Number: +47 67236122; Email: safora.johansen@oslomet.no
• Study Contact Backup: Name: Mette Karen F Henning, MSC; Phone Number: +47 95907541; Email: mettekar@oslomet.no

Study Locations

• Norway
  • Oslo, Norway, 0130
    • OsloMet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing chest CT examination between August 2019 and September 2021
• age > 18 years

Exclusion Criteria:

• hemodynamic instability
• cardiac failure
• pacemaker
• renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73 m2)
• contraindications to contrast enhanced CT
• age < 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fixed group; They received a fixed amount of contrast media prior to CT scan	Other: Adopted contrast media amount by using different approaches; Using different contrast media approaches recommended by literature to explore the impact on the contrast enhancement in chest CT
Active Comparator: body composition tailored group; They received a body tailored amount of contrast media prior to CT scan	Other: Adopted contrast media amount by using different approaches; Using different contrast media approaches recommended by literature to explore the impact on the contrast enhancement in chest CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast medium protocols in routine chest CT - A survey study	survey of what kind of contrast medium approaches are used in European hospitals	15 months

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Collaborators: Oslo University Hospital
• Investigators: Study Director: Safora F Johansen, PhD, Oslo Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 2016/674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No