NCT04300972

Brief Summary

The will compare two different ways of administering contrast media in CT exams of the chest:

  1. 1.a fixed dose of contrast medium
  2. 2.a weight- and body-type-adapted dose of contrast medium

Trial Health

100
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

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

June 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 4, 2020

Last Update Submit

March 5, 2020

Conditions

Radiography, Thoracic

Keywords

computed tomographycontrast doseweight

Outcome Measures

Primary Outcomes (1)

  • CT density of large vessel, measured in Hounsfield units (HU) in the imaging software (PACS)

    immediately after imaging

Study Arms (2)

fixed dose

OTHER
Diagnostic Test: Standard dose

weight and body type adapted dose

EXPERIMENTAL
Diagnostic Test: Body/weight adaption

Interventions

Body/weight adaptionDIAGNOSTIC_TEST

contrast media dose is adapted to weight and body type

weight and body type adapted dose
Standard doseDIAGNOSTIC_TEST

a fixed amount of contrast media is used, independently of weight and body type

fixed dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • referral indicates the need for contrast administration (as decided by a radiologist)

You may not qualify if:

  • impaired renal function (glomerular filtration rate \<60 ml/min)
  • congenital heart disease (as indicated by referral)
  • congestive heart failure (as indicated by referral)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 9, 2020

Study Start

June 15, 2016

Primary Completion

October 15, 2016

Study Completion

October 15, 2016

Last Updated

March 9, 2020

Record last verified: 2020-03