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

NCT04813432 | Unknown

• 1 other identifier: EPN Diarienr. 2018/859-31
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (22)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Interventions

Computed Tomography of the Abdomen DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Radiology Department, Karolinska Huddinge university hospital

Stockholm, 14186, Sweden

Location

Related Publications (12)

• 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.

  PMID: 20574084 BACKGROUND

• 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. doi: 10.2214/AJR.06.0372.

  PMID: 17312064 BACKGROUND

• Bae KT, Heiken JP. Scan and contrast administration principles of MDCT. Eur Radiol. 2005 Dec;15 Suppl 5:E46-59. doi: 10.1007/s10406-005-0165-y.

  PMID: 18637230 BACKGROUND

• 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.

  PMID: 21498281 BACKGROUND

• 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.

  PMID: 21498280 BACKGROUND

• 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.

  PMID: 19195531 BACKGROUND

• 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.

  PMID: 22237307 BACKGROUND

• 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. doi: 10.2214/AJR.04.1878.

  PMID: 16794136 BACKGROUND

• 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. doi: 10.1148/radiology.195.2.7724752.

  PMID: 7724752 BACKGROUND

• 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. doi: 10.1016/j.ejrad.2005.11.037. Epub 2006 Jan 18.

  PMID: 16417983 BACKGROUND

• 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. doi: 10.1148/radiol.2412051107. Epub 2006 Sep 18.

  PMID: 16982815 BACKGROUND

• Tang A, Billiard JS, Chagnon DO, Rizk F, Olivie 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.

  PMID: 25018069 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases

Study Officials

• Katharina Brehmer, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: March 24, 2021
• Study Start: September 10, 2018
• Primary Completion: January 26, 2020
• Study Completion: May 1, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)