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

Sponsor
Karolinska Institutet (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04813432
Collaborator
(none)
50
1
31.7
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Computed Tomography of the Abdomen

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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
Low Dose Multi-arterial Phase CT Imaging for Improved Detection of Liver Tumors and Pancreatic Masses
Actual Study Start Date :
Sep 10, 2018
Actual Primary Completion Date :
Jan 26, 2020
Anticipated Study Completion Date :
May 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Peak enhancement values measured in Hounsfield units(HU) in abdominal aorta. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in abdominal aorta.

  2. Peak enhancement times measured in seconds in abdominal aorta. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in abdominal aorta.

  3. Peak enhancement values measured in Hounsfield units(HU) in celiac trunc. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in celiac trunc.

  4. Peak enhancement times measured in seconds in celiac trunc. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in celiac trunc.

  5. Peak enhancement values measured in Hounsfield units(HU) in superior mesenteric artery (SMA). [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in SMA.

  6. Peak enhancement times measured in seconds in superior mesenteric artery (SMA). [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in SMA.

  7. Peak enhancement values measured in Hounsfield units(HU) in hepatic artery. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in hepatic artery.

  8. Peak enhancement times measured in seconds in hepatic artery. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in hepatic artery.

  9. Peak enhancement values measured in Hounsfield units(HU) in portal vein. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in portal vein.

  10. Peak enhancement times measured in seconds in portal vein. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in portal vein.

  11. Peak enhancement values measured in Hounsfield units(HU) in pancreas parenchyma. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in pancreas parenchyma.

  12. Peak enhancement values measured in Hounsfield units(HU) in pancreatic lesions. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in pancreatic lesions.

  13. Peak enhancement times measured in seconds in pancreas parenchyma. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in pancreas parenchyma.

  14. Peak enhancement times measured in seconds in pancreatic lesions. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in pancreatic lesions.

  15. Peak enhancement values measured in Hounsfield units(HU) in liver parenchyma. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in liver parenchyma.

  16. Peak enhancement values measured in Hounsfield units(HU) in hepatic lesions. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in hepatic lesions.

  17. Peak enhancement times measured in seconds in liver parenchyma. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in liver parenchyma.

  18. Peak enhancement times measured in seconds in hepatic lesions. [at the time of intervention (= Multi-phasic CT scan of the abdomen)]

    Creation of time attenuation curves (TAC) in hepatic lesions.

  19. highest enhancement difference between a hepatic lesion and background liver parenchyma [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

  20. time-point of highest enhancement difference between a hepatic lesion and background liver parenchyma [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

  21. highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma [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

  22. time-point of highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Radiology Department, Karolinska Huddinge university hospital Stockholm Sweden 14186

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

  • Principal Investigator: Katharina Brehmer, MD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Katharina Brehmer, principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04813432
Other Study ID Numbers:
  • EPN Diarienr. 2018/859-31
First Posted:
Mar 24, 2021
Last Update Posted:
Mar 24, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Katharina Brehmer, principal investigator, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2021