NCT05645796

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

March 29, 2023

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

November 28, 2022

Last Update Submit

March 27, 2023

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Fixed group

ACTIVE COMPARATOR

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

Other: Adopted contrast media amount by using different approaches

body composition tailored group

ACTIVE COMPARATOR

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

Other: Adopted contrast media amount by using different approaches

Interventions

Adopted contrast media amount by using different approachesOTHER

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

Fixed groupbody composition tailored group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OsloMet University

Oslo, 0130, Norway

Location

Related Publications (1)

  • Henning MK, Gunn C, Arenas-Jimenez J, Johansen S. Strategies for calculating contrast media dose for chest CT. Eur Radiol Exp. 2023 Jun 12;7(1):29. doi: 10.1186/s41747-023-00345-w.

    PMID: 37303003DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Safora F Johansen, PhD

    Oslo Metropolitan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients receiving contrast enhanced chest CT examination
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Two groups receiving contrast medium based on different approaches are included and compared with each other
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 12, 2022

Study Start

August 2, 2021

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

March 29, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)