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

NCT ID: NCT04813432

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-10

Study Completion Date

2021-05-31

Brief Summary

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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

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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

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Contrast Media Computed Tomography Imaging Pancreatic Cancer Hepatic Cancer

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Katharina Brehmer

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katharina Brehmer, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Radiology Department, Karolinska Huddinge university hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 20574084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17312064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18637230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21498281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21498280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19195531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22237307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16794136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7724752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16417983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16982815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25018069 (View on PubMed)

Other Identifiers

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EPN Diarienr. 2018/859-31

Identifier Type: -

Identifier Source: org_study_id

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