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A new liposomal liver-specific contrast agent for CT: first human phase-I clinical trial assessing efficacy and safety

Leander, Peter LU ; Höglund, Peter LU ; Borseth, Arve; Kloster, Yngvil and Berg, Arne (2001) In European Radiology 11(4). p.698-704
Abstract
In this first clinical trial liposome-encapsulated iodixanol, CT particles (CTP) were studied. The aims of the present trial were to assess the efficacy of CTP in CT and to determine the safety of different doses of CTP. A total of 47 healthy volunteers were enrolled in the present study. The CTP was administered at doses 10, 30, 70 and 100 mg encapsulated I/kg bw. Efficacy was assessed using single-slice CT of the abdomen and evaluated by dose-response attenuation curves over time in liver, spleen, and abdominal vessels. Safety was assessed by blood tests, clinical examinations and recording of subjective adverse events (AE). The attenuations in liver tissue increased with the dose and maximal values above baseline were 20, 39 and 45 HU... (More)
In this first clinical trial liposome-encapsulated iodixanol, CT particles (CTP) were studied. The aims of the present trial were to assess the efficacy of CTP in CT and to determine the safety of different doses of CTP. A total of 47 healthy volunteers were enrolled in the present study. The CTP was administered at doses 10, 30, 70 and 100 mg encapsulated I/kg bw. Efficacy was assessed using single-slice CT of the abdomen and evaluated by dose-response attenuation curves over time in liver, spleen, and abdominal vessels. Safety was assessed by blood tests, clinical examinations and recording of subjective adverse events (AE). The attenuations in liver tissue increased with the dose and maximal values above baseline were 20, 39 and 45 HU at the doses 30, 70 and 100 mg encapsulated I/kg bw, respectively. Maximal increases were seen 12.5 min after contrast administration. As for liver, the attenuations in spleen increased with the dose, but higher attenuations were obtained. In early images clinically significant enhancement was seen in abdominal vessels. Mild and moderate subjective AE were encountered at the doses 70 and 100 mg encapsulated I/kg bw. The CTP is efficacious in enhancing hepatic and splenic tissues and in early imaging of abdominal vessels. Adverse event precludes a clinical use of CTP in the current formulation. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Liver, CT, Liposome encapsulated, Contrast media
in
European Radiology
volume
11
issue
4
pages
698 - 704
publisher
Springer
external identifiers
  • pmid:11354769
  • scopus:0034879624
ISSN
0938-7994
DOI
10.1007/s003300000712
language
English
LU publication?
yes
id
775af411-06d9-4d7e-afc3-d756dd0d6447 (old id 1122003)
date added to LUP
2008-07-03 09:51:42
date last changed
2018-01-07 05:15:50
@article{775af411-06d9-4d7e-afc3-d756dd0d6447,
  abstract     = {In this first clinical trial liposome-encapsulated iodixanol, CT particles (CTP) were studied. The aims of the present trial were to assess the efficacy of CTP in CT and to determine the safety of different doses of CTP. A total of 47 healthy volunteers were enrolled in the present study. The CTP was administered at doses 10, 30, 70 and 100 mg encapsulated I/kg bw. Efficacy was assessed using single-slice CT of the abdomen and evaluated by dose-response attenuation curves over time in liver, spleen, and abdominal vessels. Safety was assessed by blood tests, clinical examinations and recording of subjective adverse events (AE). The attenuations in liver tissue increased with the dose and maximal values above baseline were 20, 39 and 45 HU at the doses 30, 70 and 100 mg encapsulated I/kg bw, respectively. Maximal increases were seen 12.5 min after contrast administration. As for liver, the attenuations in spleen increased with the dose, but higher attenuations were obtained. In early images clinically significant enhancement was seen in abdominal vessels. Mild and moderate subjective AE were encountered at the doses 70 and 100 mg encapsulated I/kg bw. The CTP is efficacious in enhancing hepatic and splenic tissues and in early imaging of abdominal vessels. Adverse event precludes a clinical use of CTP in the current formulation.},
  author       = {Leander, Peter and Höglund, Peter and Borseth, Arve and Kloster, Yngvil and Berg, Arne},
  issn         = {0938-7994},
  keyword      = {Liver,CT,Liposome encapsulated,Contrast media},
  language     = {eng},
  number       = {4},
  pages        = {698--704},
  publisher    = {Springer},
  series       = {European Radiology},
  title        = {A new liposomal liver-specific contrast agent for CT: first human phase-I clinical trial assessing efficacy and safety},
  url          = {http://dx.doi.org/10.1007/s003300000712},
  volume       = {11},
  year         = {2001},
}