Proven in clinical trials
Lumentin®44 has succesfully passed Phase 1 and 2-trials and is now ready for
phase 3 clinical studies.
| Pilot Study 2016 | Phase 2a 2017-2018 | Phase 2b 2020-2022 | Phase 2 2023 | Phase 3 | |
|---|---|---|---|---|---|
| Key take-aways | Successfully filled the small intestine with negative contrast Easily consumable, exhibited no significant side effects | Comparison between Lumentin, Omnipaque and Movieprep Superior performance compared to leading CT contrast agents | CTE with Luentin®44 vs MRE – “blind” test (radiologists unaware of clinical information) CT with Lumentin equally good or better than MRE in 88% of cases | Investigation of MRE image quality of Lumentin® 44 MRE-scans Results showed potential and raised interest to MRE-Lumentin with patients with Crohn’s disease | Demonstrate Lumentin’s superiority over Omnipaque This time at a greater scale in both Europe and the US |
| Patients | 25 healthy volunteers compared with 50 historical controls | 45 oncological volunteers with no anomalies, no bowel symptons, remitted to CT-scan | 60 patients with Crohn’s disease | 10 healthy volunteers | Multicenter trials 300-400 patients |
| Imaging | CT-scan | CT-scan | CT-scan and MRE | MRE | CT-scan |
| IMP | Lumentin (60% v/v air content) | Lumentin, Moviprep, Omnipaque | Lumentin for CTE; Moviprep for MRE | Lumentin | Lumentin, Omnipaque |
| IV Contrast agent | None (Iodine contrast Omnipaque 350 mg l/mL was not used) | Iodine contrast (Omnipaque 350 mg l/mL) | Iodine contrast (Omnipaque 350 mg l/mL for CTE; Gadolinium for MRE) | Gadolinium | Iodine contrast (Omnipaque 350 mg l/mL) |
“Never seen a real per-oral negative filling agent before, we have been looking for this kind of product.”
Stuart Taylor
MD, PhD, Radiologist, UK