Contrast MediaNCT04813432
Multiple Arterial Phase Computed Tomography Examination to Improve Detection of Tumors in the Liver and Pancreas
An observational study of Contrast Media and Computed Tomography, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Contrast Media, Computed Tomography, Imaging
- What is being tested?
- Computed Tomography of the Abdomen
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 10 Sep 2018to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients, who are scheduled for a multiphasic liver or pancreas CT because of known or suspected malignancy in the liver or pancreas.
Who cannot join
- below 50 years of age, contrast media allergy or decreased kidney function
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Radiology Department, Karolinska Huddinge university hospital
Stockholm, 14186
About this study
Official title: Low Dose Multi-arterial Phase CT Imaging for Improved Detection of Liver Tumors and Pancreatic Masses
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.
Read the 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
- Contrast Media, Computed Tomography, Imaging, Pancreatic Cancer, Hepatic Cancer
- Being tested
- Computed Tomography of the Abdomen
- Keywords
- computed tomography, CT angiography, hepatic imaging, pancreatic imaging, hepatocellular cancer, pancreatic adenocarcinoma, liver, pancreas
- Medical subject headings
- Pancreatic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography of the AbdomenDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak enhancement values measured in Hounsfield units(HU) in abdominal aorta.
Creation of time attenuation curves (TAC) in abdominal aorta.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start10 Sep 2018
- Primary completion26 Jan 2020
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Contrast MediaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Brehmer, Karolinska Institutet
- Investigators
- Katharina Brehmer, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813432
- Sponsor's protocol ID
- EPN Diarienr. 2018/859-31
- Status last verified
- Mar 2021
- First submitted
- 21 Nov 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20574084Kondo 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.
PubMed 17312064Bae 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.
PubMed 18637230Rengo 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.
PubMed 21498281Rengo 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.
PubMed 21498280Fleischmann 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.
PubMed 19195531Delrue 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.
PubMed 22237307Goshima 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.
PubMed 16794136Heiken 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.
PubMed 7724752Ichikawa 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.
PubMed 16417983Schueller 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.
PubMed 16982815Tang 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.
PubMed 25018069
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Multi-arterial Phase CT Imaging for Improved Detection of Liver Tumors and Pancreatic Masses
- ClinicalTrials.gov ID
- NCT04813432
- Acronym / sponsor ID
- EPN Diarienr. 2018/859-31
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients, who are scheduled for a multiphasic liver or pancreas CT because of known or suspected malignancy in the liver or pancreas.
Key exclusion criteria (1 listed)
- below 50 years of age, contrast media allergy or decreased kidney function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed 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. | Diagnostic test | – |
Primary outcome
Peak enhancement values measured in Hounsfield units(HU) in abdominal aorta.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in abdominal aorta.
Peak enhancement times measured in seconds in abdominal aorta.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in abdominal aorta.
Peak enhancement values measured in Hounsfield units(HU) in celiac trunc.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in celiac trunc.
Peak enhancement times measured in seconds in celiac trunc.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in celiac trunc.
Peak enhancement values measured in Hounsfield units(HU) in superior mesenteric artery (SMA).
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in SMA.
Peak enhancement times measured in seconds in superior mesenteric artery (SMA).
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in SMA.
Peak enhancement values measured in Hounsfield units(HU) in hepatic artery.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in hepatic artery.
Peak enhancement times measured in seconds in hepatic artery.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in hepatic artery.
Peak enhancement values measured in Hounsfield units(HU) in portal vein.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in portal vein.
Peak enhancement times measured in seconds in portal vein.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in portal vein.
Peak enhancement values measured in Hounsfield units(HU) in pancreas parenchyma.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in pancreas parenchyma.
Peak enhancement values measured in Hounsfield units(HU) in pancreatic lesions.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in pancreatic lesions.
Peak enhancement times measured in seconds in pancreas parenchyma.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in pancreas parenchyma.
Peak enhancement times measured in seconds in pancreatic lesions.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in pancreatic lesions.
Peak enhancement values measured in Hounsfield units(HU) in liver parenchyma.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in liver parenchyma.
Peak enhancement values measured in Hounsfield units(HU) in hepatic lesions.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in hepatic lesions.
Peak enhancement times measured in seconds in liver parenchyma.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in liver parenchyma.
Peak enhancement times measured in seconds in hepatic lesions.
Time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)
Creation of time attenuation curves (TAC) in hepatic lesions.
highest enhancement difference between a hepatic lesion and background liver parenchyma
Time frame: 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
time-point of highest enhancement difference between a hepatic lesion and background liver parenchyma
Time frame: 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
highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma
Time frame: 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
time-point of highest enhancement difference between a pancreatic lesion and background pancreatic parenchyma
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 20574084Bae 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.
- Background: PubMed 17312064Kondo 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.
- Background: PubMed 18637230Bae 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.
- Background: PubMed 21498281Rengo 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.
- Background: PubMed 21498280Rengo 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.
- Background: PubMed 19195531Fleischmann 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.
- Background: PubMed 22237307Delrue 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.
- Background: PubMed 16794136Goshima 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.
- Background: PubMed 7724752Heiken 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.
- Background: PubMed 16417983Ichikawa 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.
- Background: PubMed 16982815Schueller 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.
- Background: PubMed 25018069Tang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharina Brehmer, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast Media and Computed Tomography, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak enhancement values measured in Hounsfield units(HU) in abdominal aorta. (time frame: at the time of intervention (= Multi-phasic CT scan of the abdomen)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813432, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.