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Comparison of Contrast Agent Administration Protocols

5. marts 2020 opdateret af: Kristian Fosså, Oslo University Hospital

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

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

The goal is to see if one protocol is superior to the other in reliably producing diagnostic CT images.

Studieoversigt

Detaljeret beskrivelse

The continuing advances in computed tomographic (CT) technology in the past decades have provided ongoing opportunities to improve CT image quality, clinical practice and discover new clinical CT imaging applications. New CT technology, however, has introduced new challenges in clinical radiology practice. One of the challenges deals with intravenous contrast medium (CM) administration. Although multidetector CT allows more efficient and flexible use of contrast medium than single-detector CT, to fully reap the benefits of multidetector CT, certain technical challenges involving maximum contrast enhancement and optimal contrast material delivery must be met (1). While CT technology has evolved, the practice of CT intravenous CM administration has been continually debated and updated. The users of new CT technology, accompanied with its newly added technical complexity, discover they fall short of achieving a desired image quality with the traditional standard administration of CM. This entails a change in practice. In the department of Radiology at St Olav University Hospital (SOH), a new protocol for CM administration is now developed and is ready for implementation. This protocol is based on a body weight adapted CM administration, while the current protocol has a fixed CM injection. In this study, this newly CM administration protocol for thoracic CT will be compared to the fixed CM injection protocol. To our knowledge, very few studies (2) have been published on the use of body weight adapted injection protocols for Thoracic CT. Most of the studies report the impact of body weight adapted CM injection protocols for the coronary arteries of CT angiography (3- 5). Therefore, the aim of this study is to determine whether individually tailored protocol(s) for the injection of CM results in higher and more homogeneous vascular attenuation at thoracic CT compared with conventional injection protocols using fixed injection parameters. We know that to achieve optimal contrast enhancement in thoracic CT involves essential factors such as CT tube voltage and CT attenuation, patient factors, CM factors and CT scanning factors (1) and thus all these factors will be addressed and discussed in this investigation.

Specific aims of the study:

  1. To assess and compare the CT attenuation achieved with both protocols
  2. Compare the required amount of CM using weight adapted CM protocol and fixed CM injection protocol
  3. Compare the quality of the images using weight adapted CM protocol and fixed CM injection protocol

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

67

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

All patients referred for a thoracic CT (only) at St. Olavs Hospital will be screened for eligibility Inclusion criteria are

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

Exclusion criteria are:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: fixed dose
a fixed amount of contrast media is used, independently of weight and body type
Eksperimentel: weight and body type adapted dose
contrast media dose is adapted to weight and body type

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
CT density of large vessel, measured in Hounsfield units (HU) in the imaging software (PACS)
Tidsramme: immediately after imaging
immediately after imaging

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juni 2016

Primær færdiggørelse (Faktiske)

15. oktober 2016

Studieafslutning (Faktiske)

15. oktober 2016

Datoer for studieregistrering

Først indsendt

4. marts 2020

Først indsendt, der opfyldte QC-kriterier

5. marts 2020

Først opslået (Faktiske)

9. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CMProtokoll

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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