A novel food-based negative oral contrast agent compared with two conventional oral contrast agents in abdominal CT : a three-arm parallel blinded randomised controlled single-centre trial
(2022) In European Radiology Experimental 6(1).- Abstract
Background: A negative oral contrast agent (OCA) has been long sought for, to better delineate the bowel and visualise surrounding structures. Lumentin® 44 (L44) is a new OCA formulated to fill the entire small bowel. The aim of this study was to compare L44 with positive and neutral conventional OCA in abdominal computed tomography (CT). Methods: Forty-five oncologic patients were randomised to receive either L44 or one of the two comparators (MoviPrep® or diluted Omnipaque®). Abdominal CT examinations with intravenous contrast agent were acquired according to standard protocols. The studies were read independently by two senior radiologists. Results: The mean intraluminal Hounsfield units (HU)-values of regions-of-interest (ROIs) for... (More)
Background: A negative oral contrast agent (OCA) has been long sought for, to better delineate the bowel and visualise surrounding structures. Lumentin® 44 (L44) is a new OCA formulated to fill the entire small bowel. The aim of this study was to compare L44 with positive and neutral conventional OCA in abdominal computed tomography (CT). Methods: Forty-five oncologic patients were randomised to receive either L44 or one of the two comparators (MoviPrep® or diluted Omnipaque®). Abdominal CT examinations with intravenous contrast agent were acquired according to standard protocols. The studies were read independently by two senior radiologists. Results: The mean intraluminal Hounsfield units (HU)-values of regions-of-interest (ROIs) for each subsegment of small bowel and treatment group were -404.0 HU for L44, 166.1 HU for Omnipaque®, and 16.7 HU for MoviPrep® (L44 versus Omnipaque, p < 0.001: L44 versus MoviPrep p < 0.001; Omnipaque versus MoviPrep, p = 0.003). Adverse events, only mild, using L44 were numerically fewer than for using conventional oral contrast agents. Visualisation of abdominal structures beyond the small bowel was similar to the comparators. Conclusions: L44 is a negative OCA with luminal radiodensity at approximately -400 HU creating a unique small bowel appearance on CT scans. The high bowel wall-to-lumen contrast may enable improved visualisation in a range of pathologic conditions. L44 showed a good safety profile and was well accepted by patients studied. Trial registration: EudraCT (2017-002368-42) and in ClinicalTrials.gov (NCT03326518).
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- author
- Leander, Peter LU ; Stathis, Georgios ; Casal-Dujat, Lucia LU ; Boman, Karolina ; Adnerhill, Ingvar LU ; Marsal, Jan LU ; Böök, Olof and Fork, Thomas LU
- organization
- publishing date
- 2022
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Contrast media, Intestine (small), Iohexol, MoviPrep, Tomography (x-ray computed)
- in
- European Radiology Experimental
- volume
- 6
- issue
- 1
- article number
- 15
- publisher
- Springer
- external identifiers
-
- pmid:35378633
- scopus:85127492589
- ISSN
- 2509-9280
- DOI
- 10.1186/s41747-022-00267-z
- language
- English
- LU publication?
- yes
- id
- b592dc41-2d80-4b23-88dc-ed18538a89e7
- date added to LUP
- 2022-06-01 14:12:05
- date last changed
- 2024-06-13 14:24:52
@article{b592dc41-2d80-4b23-88dc-ed18538a89e7,
abstract = {{<p>Background: A negative oral contrast agent (OCA) has been long sought for, to better delineate the bowel and visualise surrounding structures. Lumentin® 44 (L44) is a new OCA formulated to fill the entire small bowel. The aim of this study was to compare L44 with positive and neutral conventional OCA in abdominal computed tomography (CT). Methods: Forty-five oncologic patients were randomised to receive either L44 or one of the two comparators (MoviPrep® or diluted Omnipaque®). Abdominal CT examinations with intravenous contrast agent were acquired according to standard protocols. The studies were read independently by two senior radiologists. Results: The mean intraluminal Hounsfield units (HU)-values of regions-of-interest (ROIs) for each subsegment of small bowel and treatment group were -404.0 HU for L44, 166.1 HU for Omnipaque®, and 16.7 HU for MoviPrep® (L44 versus Omnipaque, p < 0.001: L44 versus MoviPrep p < 0.001; Omnipaque versus MoviPrep, p = 0.003). Adverse events, only mild, using L44 were numerically fewer than for using conventional oral contrast agents. Visualisation of abdominal structures beyond the small bowel was similar to the comparators. Conclusions: L44 is a negative OCA with luminal radiodensity at approximately -400 HU creating a unique small bowel appearance on CT scans. The high bowel wall-to-lumen contrast may enable improved visualisation in a range of pathologic conditions. L44 showed a good safety profile and was well accepted by patients studied. Trial registration: EudraCT (2017-002368-42) and in ClinicalTrials.gov (NCT03326518).</p>}},
author = {{Leander, Peter and Stathis, Georgios and Casal-Dujat, Lucia and Boman, Karolina and Adnerhill, Ingvar and Marsal, Jan and Böök, Olof and Fork, Thomas}},
issn = {{2509-9280}},
keywords = {{Contrast media; Intestine (small); Iohexol; MoviPrep; Tomography (x-ray computed)}},
language = {{eng}},
number = {{1}},
publisher = {{Springer}},
series = {{European Radiology Experimental}},
title = {{A novel food-based negative oral contrast agent compared with two conventional oral contrast agents in abdominal CT : a three-arm parallel blinded randomised controlled single-centre trial}},
url = {{http://dx.doi.org/10.1186/s41747-022-00267-z}},
doi = {{10.1186/s41747-022-00267-z}},
volume = {{6}},
year = {{2022}},
}