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Improved Chest CT Diagnostic and Contrast Medium Administration

Primary Purpose

Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Adopted contrast media amount by using different approaches

About this trial

This is an interventional diagnostic trial for Pulmonary Disease

Eligibility Criteria

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

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

Sites / Locations

OsloMet University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Fixed group

body composition tailored group

Arm Description

They received a fixed amount of contrast media prior to CT scan

They received a body tailored amount of contrast media prior to CT scan

Outcomes

Primary Outcome Measures

Contrast medium protocols in routine chest CT - A survey study

survey of what kind of contrast medium approaches are used in European hospitals

Secondary Outcome Measures

Full Information

NCT ID

NCT05645796

First Posted

November 28, 2022

Last Updated

March 27, 2023

Sponsor

Oslo Metropolitan University

Collaborators

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05645796

Brief Title

Improved Chest CT Diagnostic and Contrast Medium Administration

Official Title

Improved Chest CT Diagnostic and Contrast Medium Administration

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

August 2, 2021 (Actual)

Primary Completion Date

January 15, 2023 (Actual)

Study Completion Date

January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo Metropolitan University

Collaborators

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

Pulmonary Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two groups receiving contrast medium based on different approaches are included and compared with each other

Masking

Participant

Masking Description

Patients receiving contrast enhanced chest CT examination

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fixed group

Arm Type

Active Comparator

Arm Description

They received a fixed amount of contrast media prior to CT scan

Arm Title

body composition tailored group

Arm Type

Active Comparator

Arm Description

They received a body tailored amount of contrast media prior to CT scan

Intervention Type

Other

Intervention Name(s)

Adopted contrast media amount by using different approaches

Intervention Description

Using different contrast media approaches recommended by literature to explore the impact on the contrast enhancement in chest CT

Primary Outcome Measure Information:

Title

Contrast medium protocols in routine chest CT - A survey study

Description

survey of what kind of contrast medium approaches are used in European hospitals

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Safora F Johansen, PhD

Organizational Affiliation

Oslo Metropolitan University

Official's Role

Study Director

Facility Information:

Facility Name

OsloMet University

City

Oslo

ZIP/Postal Code

0130

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

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Improved Chest CT Diagnostic and Contrast Medium Administration

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