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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04813432
• Other study ID #: EPN Diarienr. 2018/859-31
• Status: Active, not recruiting
• Start date: September 10, 2018
• Est. completion date: May 2021

Study information

• Verified date: March 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 2021
• Est. primary completion date: January 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Computed Tomography
• Contrast Media
• Hepatic Cancer
• Imaging
• Liver Neoplasms
• Pancreatic Cancer

Intervention

Diagnostic Test:
• Computed Tomography of the Abdomen
Multi-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.

Locations

Country	Name	City	State
Sweden	Radiology Department, Karolinska Huddinge university hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (12)

Bae KT, Heiken JP. Scan and contrast administration principles of MDCT. Eur Radiol. 2005 Dec;15 Suppl 5:E46-59. Review. — View Citation

Bae KT. Intravenous contrast medium administration and scan timing at CT: considerations and approaches. Radiology. 2010 Jul;256(1):32-61. doi: 10.1148/radiol.10090908. Review. — View Citation

Delrue L, Blanckaert P, Mertens D, De Waele J, Ceelen W, Achten E, Duyck P. Variability of CT contrast enhancement in the pancreas: a cause for concern? Pancreatology. 2011;11(6):588-94. doi: 10.1159/000334547. Epub 2012 Jan 11. — View Citation

Fleischmann D, Kamaya A. Optimal vascular and parenchymal contrast enhancement: the current state of the art. Radiol Clin North Am. 2009 Jan;47(1):13-26. doi: 10.1016/j.rcl.2008.10.009. Review. — View Citation

Goshima S, Kanematsu M, Kondo H, Yokoyama R, Miyoshi T, Nishibori H, Kato H, Hoshi H, Onozuka M, Moriyama N. MDCT of the liver and hypervascular hepatocellular carcinomas: optimizing scan delays for bolus-tracking techniques of hepatic arterial and portal venous phases. AJR Am J Roentgenol. 2006 Jul;187(1):W25-32. — View Citation

Heiken JP, Brink JA, McClennan BL, Sagel SS, Crowe TM, Gaines MV. Dynamic incremental CT: effect of volume and concentration of contrast material and patient weight on hepatic enhancement. Radiology. 1995 May;195(2):353-7. — View Citation

Ichikawa T, Erturk SM, Araki T. Multiphasic contrast-enhanced multidetector-row CT of liver: contrast-enhancement theory and practical scan protocol with a combination of fixed injection duration and patients' body-weight-tailored dose of contrast material. Eur J Radiol. 2006 May;58(2):165-76. Epub 2006 Jan 18. Review. — View Citation

Kondo H, Kanematsu M, Goshima S, Miyoshi T, Shiratori Y, Onozuka M, Moriyama N, Bae KT. MDCT of the pancreas: optimizing scanning delay with a bolus-tracking technique for pancreatic, peripancreatic vascular, and hepatic contrast enhancement. AJR Am J Roentgenol. 2007 Mar;188(3):751-6. — View Citation

Rengo M, Bellini D, De Cecco CN, Osimani M, Vecchietti F, Caruso D, Maceroni MM, Lucchesi P, Iafrate F, Palombo E, Paolantonio P, Ferrari R, Laghi A. The optimal contrast media policy in CT of the liver. Part II: Clinical protocols. Acta Radiol. 2011 Jun 1;52(5):473-80. doi: 10.1258/ar.2011.100500. Epub 2011 Mar 28. Review. — View Citation

Rengo M, Bellini D, De Cecco CN, Osimani M, Vecchietti F, Caruso D, Maceroni MM, Lucchesi P, Iafrate F, Paolantonio P, Ferrari R, Laghi A. The optimal contrast media policy in CT of the liver. Part I: Technical notes. Acta Radiol. 2011 Jun 1;52(5):467-72. doi: 10.1258/ar.2011.100499. Epub 2011 Mar 17. Review. — View Citation

Schueller G, Schima W, Schueller-Weidekamm C, Weber M, Stift A, Gnant M, Prokesch R. Multidetector CT of pancreas: effects of contrast material flow rate and individualized scan delay on enhancement of pancreas and tumor contrast. Radiology. 2006 Nov;241(2):441-8. Epub 2006 Sep 18. — View Citation

Tang A, Billiard JS, Chagnon DO, Rizk F, Olivié D, Turcotte S, Chagnon M, Lepanto L. Optimal Pancreatic Phase Delay with 64-Detector CT Scanner and Bolus-tracking Technique. Acad Radiol. 2014 Aug;21(8):977-85. doi: 10.1016/j.acra.2014.04.004. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak enhancement values measured in Hounsfield units(HU) in abdominal aorta.	Creation of time attenuation curves (TAC) in abdominal aorta.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in abdominal aorta.	Creation of time attenuation curves (TAC) in abdominal aorta.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement values measured in Hounsfield units(HU) in celiac trunc.	Creation of time attenuation curves (TAC) in celiac trunc.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in celiac trunc.	Creation of time attenuation curves (TAC) in celiac trunc.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement values measured in Hounsfield units(HU) in superior mesenteric artery (SMA).	Creation of time attenuation curves (TAC) in SMA.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in superior mesenteric artery (SMA).	Creation of time attenuation curves (TAC) in SMA.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement values measured in Hounsfield units(HU) in hepatic artery.	Creation of time attenuation curves (TAC) in hepatic artery.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in hepatic artery.	Creation of time attenuation curves (TAC) in hepatic artery.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement values measured in Hounsfield units(HU) in portal vein.	Creation of time attenuation curves (TAC) in portal vein.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in portal vein.	Creation of time attenuation curves (TAC) in portal vein.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement values measured in Hounsfield units(HU) in pancreas parenchyma.	Creation of time attenuation curves (TAC) in pancreas parenchyma.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement values measured in Hounsfield units(HU) in pancreatic lesions.	Creation of time attenuation curves (TAC) in pancreatic lesions.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in pancreas parenchyma.	Creation of time attenuation curves (TAC) in pancreas parenchyma.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in pancreatic lesions.	Creation of time attenuation curves (TAC) in pancreatic lesions.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement values measured in Hounsfield units(HU) in liver parenchyma.	Creation of time attenuation curves (TAC) in liver parenchyma.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement values measured in Hounsfield units(HU) in hepatic lesions.	Creation of time attenuation curves (TAC) in hepatic lesions.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in liver parenchyma.	Creation of time attenuation curves (TAC) in liver parenchyma.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	Peak enhancement times measured in seconds in hepatic lesions.	Creation of time attenuation curves (TAC) in hepatic lesions.	at the time of intervention (= Multi-phasic CT scan of the abdomen)
Primary	highest enhancement difference between a hepatic lesion and background liver parenchyma	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)
Primary	time-point of highest enhancement difference between a hepatic lesion and background liver parenchyma	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)
Primary	highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma	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)
Primary	time-point of highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma	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)