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UnknownNCT04813432

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTComputed Tomography of the AbdomenMulti-phasic CT scan of the abdomen: 1 low dose unenhanced scan + 10 low dose arterial perfusion scans + 1 portal-venous phase scan + 1 delayed phase scan. Bolus-tracking threshold in abdominal aorta = 160 HU. Delay of first arterial scan 5 sec after bolus-tracking threshold has been reached; and then 1 scan every 3 sec until 35 sec after threshold. Contrast media (CM) protocol: fixed injection duration: 25 sec, body weight-adjusted CM volume: 750 mgI/kg bodyweight (max 80 kg women, 100kg men), Iomeron 400mgI/ml. Image-reconstruction: Motion-correction, noise-reduction and fusion of the best arterial time points to reconstruct one optimally timed early and one optimally timed late arterial phase.

Timeline

Start date
2018-09-10
Primary completion
2020-01-26
Completion
2021-05-01
First posted
2021-03-24
Last updated
2021-03-24

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT04813432. Inclusion in this directory is not an endorsement.