Multiple Arterial Phase Computed Tomography Examination to Improve Detection of Tumors in the Liver and Pancreas

March 22, 2021 updated by: Katharina Brehmer, Karolinska Institutet

Low Dose Multi-arterial Phase CT Imaging for Improved Detection of Liver Tumors and Pancreatic Masses

To examine inter-subject variations of optimal late arterial phase contrast-enhancement defined as the greatest difference in contrast attenuation of hepatocellular carcinoma (HCC) compared to background liver parenchyma resp. pancreatic lesions compared to pancreatic parenchyma. To evaluate which time-points best depict an optimal late arterial phase.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Many previous studies have analyzed and proposed different strategies to achieve optimal contrast timing and enhancement in the late arterial phase to best depict arterialized lesions in the liver and hypoattenuating tumors in the pancreas(1-12). But even with the use of state-of-the-art protocols, inter-subject variations of optimal contrast enhancement in liver lesions and pancreas parenchyma are still very common. The aim of this study is to first analyze these alterations and to, secondly, use the newly gained knowledge to design a dose-neutral multiple arterial phase protocol. An optimized arterial phase protocol might improve the detection of hepatocellular carcinoma (HCC) and/or pancreatic adenocarcinoma.

Purpose: To measure when the greatest difference in attenuation occurs in HCC compared to background liver parenchyma resp. in pancreatic lesions vs. pancreatic parenchyma. To describe the inter-subject variation of these enhancement times and to evaluate at which time-points an optimal late arterial phase can be achieved. The investigators will use the perfusion scanning technique, bolus-tracking and high body-weight-adjusted volumes of contrast media (CM).

Anticipated results: The aim is to find the best time points for optimal CM-enhancement in HCC lesions and pancreas parenchyma. The results will show the extent of the inter-subject temporal enhancement differences and will be used to design an optimized late arterial phase protocol for clinical practice and future studies.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Radiology Department, Karolinska Huddinge university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 consecutive patients, who are scheduled for a multiphasic liver or pancreas CT because of known treatment naïve or suspected HCC or pancreatic cancer.

Description

Inclusion Criteria:

  • patients, who are scheduled for a multiphasic liver or pancreas CT because of known or suspected malignancy in the liver or pancreas.

Exclusion Criteria:

  • below 50 years of age, contrast media allergy or decreased kidney function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak enhancement values measured in Hounsfield units(HU) in abdominal aorta.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in abdominal aorta.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in abdominal aorta.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in abdominal aorta.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement values measured in Hounsfield units(HU) in celiac trunc.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in celiac trunc.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in celiac trunc.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in celiac trunc.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement values measured in Hounsfield units(HU) in superior mesenteric artery (SMA).
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in SMA.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in superior mesenteric artery (SMA).
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in SMA.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement values measured in Hounsfield units(HU) in hepatic artery.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in hepatic artery.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in hepatic artery.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in hepatic artery.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement values measured in Hounsfield units(HU) in portal vein.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in portal vein.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in portal vein.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in portal vein.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement values measured in Hounsfield units(HU) in pancreas parenchyma.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in pancreas parenchyma.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement values measured in Hounsfield units(HU) in pancreatic lesions.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in pancreatic lesions.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in pancreas parenchyma.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in pancreas parenchyma.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in pancreatic lesions.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in pancreatic lesions.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement values measured in Hounsfield units(HU) in liver parenchyma.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in liver parenchyma.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement values measured in Hounsfield units(HU) in hepatic lesions.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in hepatic lesions.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in liver parenchyma.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in liver parenchyma.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
Peak enhancement times measured in seconds in hepatic lesions.
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in hepatic lesions.
at the time of intervention (= Multi-phasic CT scan of the abdomen)
highest enhancement difference between a hepatic lesion and background liver parenchyma
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
To measure the highest enhancement difference in Hounsfield units(HU) between a hepatic lesion and background liver parenchyma
at the time of intervention (= Multi-phasic CT scan of the abdomen)
time-point of highest enhancement difference between a hepatic lesion and background liver parenchyma
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
To depict the time-point of the highest enhancement difference between a hepatic lesion and background liver parenchyma by comparing their tissue attenuation curves
at the time of intervention (= Multi-phasic CT scan of the abdomen)
highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
To measure the highest enhancement difference in Hounsfield units(HU) between a pancreatic lesion and background pancreas parenchyma
at the time of intervention (= Multi-phasic CT scan of the abdomen)
time-point of highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma
Time Frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
To depict the time-point of the highest enhancement difference between a pancreatic lesion and background pancreas parenchyma by comparing their tissue attenuation curves
at the time of intervention (= Multi-phasic CT scan of the abdomen)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Katharina Brehmer, MD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

January 26, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

November 21, 2020

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN Diarienr. 2018/859-31

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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