Peritus Clinic AB, Scheelevägen 8, 223 63, Lund, Sweden.
Department of Translational Medicine, Skåne University Hospital, Lund University, 205 02, Malmö, Sweden.
Eur Radiol Exp. 2022 Apr 5;6(1):15. doi: 10.1186/s41747-022-00267-z.
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).
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.
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.
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.
EudraCT (2017-002368-42) and in ClinicalTrials.gov (NCT03326518).
长期以来，人们一直寻求一种负性口服对比剂（OCA），以更好地描绘肠道并观察周围结构。Lumentin® 44（L44）是一种新的 OCA，旨在填充整个小肠。本研究旨在比较 L44 与腹部计算机断层扫描（CT）中的阳性和中性常规 OCA。
45 例肿瘤患者随机分为 L44 组或两种对照剂（MoviPrep®或稀释 Omnipaque®）组。根据标准方案进行静脉对比剂增强的腹部 CT 检查。两名资深放射科医生独立阅读研究结果。
每个小肠亚段和治疗组的 ROI 内平均 Hounsfield 单位（HU）值分别为 L44 组-404.0 HU、Omnipaque®组 166.1 HU 和 MoviPrep®组 16.7 HU（L44 与 Omnipaque，p < 0.001；L44 与 MoviPrep，p < 0.001；Omnipaque 与 MoviPrep，p = 0.003）。使用 L44 的不良事件仅为轻度，且数量少于使用常规口服对比剂。对小肠以外腹部结构的可视化与对照剂相似。
L44 是一种负性 OCA，腔内放射密度约为-400 HU，在 CT 扫描上形成独特的小肠外观。高肠壁-肠腔对比度可能使在多种病理情况下的可视化得到改善。L44 表现出良好的安全性且被研究患者所接受。
EudraCT（2017-002368-42）和 ClinicalTrials.gov（NCT03326518）。
