Clinical trial NCT04813432: Multiple Arterial Phase Computed Tomography Examination to Improve Detection of Tumors in the Liver and Pancreas
Official title: Low Dose Multi-arterial Phase CT Imaging for Improved Detection of Liver Tumors and Pancreatic Masses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contrast Media
Computed Tomography
Imaging
Pancreatic Cancer
Hepatic Cancer
Keywords: computed tomography
CT angiography
hepatic imaging
pancreatic imaging
hepatocellular cancer
pancreatic adenocarcinoma
liver
pancreas
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak enhancement values measured in Hounsfield units(HU) in abdominal aorta.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in abdominal aorta.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement values measured in Hounsfield units(HU) in celiac trunc.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in celiac trunc.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement values measured in Hounsfield units(HU) in superior mesenteric artery (SMA).
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in superior mesenteric artery (SMA).
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement values measured in Hounsfield units(HU) in hepatic artery.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in hepatic artery.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement values measured in Hounsfield units(HU) in portal vein.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in portal vein.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement values measured in Hounsfield units(HU) in pancreas parenchyma.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement values measured in Hounsfield units(HU) in pancreatic lesions.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in pancreas parenchyma.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in pancreatic lesions.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement values measured in Hounsfield units(HU) in liver parenchyma.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement values measured in Hounsfield units(HU) in hepatic lesions.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in liver parenchyma.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: Peak enhancement times measured in seconds in hepatic lesions.
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: highest enhancement difference between a hepatic lesion and background liver parenchyma
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: time-point of highest enhancement difference between a hepatic lesion and background liver parenchyma
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
measure: time-point of highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma
timeFrame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Radiology Department, Karolinska Huddinge university hospital
Study officials:
affiliation: Karolinska Institutet
name: Katharina Brehmer, MD
role: PRINCIPAL_INVESTIGATOR
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