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1. What are the differences between LC Bead LUMI™ and LC Bead®?
2. What has the feedback from KOLs been regarding LC Bead LUMI™? BTG and many of the interventional radiologists we have spoken to are very excited by the opportunities offered by being able to actually visualize rather than infer the location of the beads during embolization therapy and at follow-up. It is believed that this will offer a new level of precision and control and allow for more real- time adjustments to optimize patient treatment. 3. Is it required to deliver LC Bead LUMI™ with contrast agent? Are specific contrast agents required? LC Bead LUMI™ must be suspended in soluble iodinated contrast (a minimum of 20ml per vial) to achieve effective delivery through microcatheters and to aid visualization during administration. Only pure contrast (i.e. undiluted) should be used. The LC Bead LUMI™ IFU recommends using contrast agents Omnipaque 350 (Iohexol 350) and Iomeron 400 (Iomeprol 400). Based on post-approval early experience, please note that Visipaque provides an even better (long and stable) suspension. LC Bead LUMI™ is visible on X-ray as the beads accumulate in the vessel and the contrast clears. 4. Which catheters should be used for optimal administration of LC Bead LUMI™? Once prepared, LC Bead LUMI™ has been tested and shown to be successfully delivered using the combinations of microsphere size, contrast medium and microcatheters shown in Table 2 in the IFU (copy provided below). A catheter with an internal diameter of ≥ 2.0 Fr (0.019 in/0.483 mm) is recommended for the 40-90um and 70-150um. A catheter with an internal diameter of ≥ 2.4 Fr (0.022 in/0.54 mm) may be preferred for 70-150um and 100-300um. Please note, following early stage experience, the recommendation is for new centers to treat using larger catheters (2.7/2.8 Fr) in initial patients to gain experience and confidence administrating, before using smaller catheters, if required.
5. What makes LC Bead LUMI™ radiopaque? LC Bead LUMI™ has been developed from the proven core chemistry used in LC Bead® with the blue dye replaced by a covalently bonded iodine to offer radiopacity. 6. How long does the radiopacity of LC Bead LUMI™ last? The radiopacity is integral to the bead and will not degrade, so LC Bead LUMI™ will be visible on imaging at long-term follow-up. 7. Under which imaging modalities can LC Bead LUMI™ be seen?
Imaging modalities with which LC Bead LUMI™ are visible include Computed Tomography (CT), Cone Beam CT and fluoroscopy and x-ray ‘single’ or ‘snap’ shot. LC Bead LUMI™ is not visible with Magnetic Resonance Imaging (MRI). Imaging protocols that visualize soluble iodinated contrast medium are suitable for LC Bead LUMI™. There is no need to recalibrate the equipment, although over time imaging manufacturers may issue guidelines or protocols to optimize visualization during LUMI-embolization procedures. Cone Beam CT is optimal, but not required.
8.a. How is LC Bead LUMI™ visualized after administration? LC Bead LUMI™ is visible under x-ray imaging as they accumulate in the embolized vessels. It can be directly visualized as the delivery contrast agent washes out. Best visualization is achieved after administration using X-ray single shot technique (also referred to as X-ray snap shot). Cone beam CT (CBCT) can also be used to visualize the beads accumulated in the vessels with multi-planar reconstructions providing 3D spatial bead location and vessel connectivity. 8.b. What should I expect in post-procedural follow up imaging? LC Bead LUMI™ is easily visualized with CT. Early experience images from various different tumor types, show discrete embolized vessels where LC Bead LUMI™ is present with no significant streak artefacts nor masking of adjacent tissue unlike commonly seen following lipiodol containing treatments. If contrast enhanced CT images are desired, obtaining a non-contrast image may be helpful to discriminate LC Bead LUMI™ from contrast enhancement.
The radiopacity of LC Bead LUMI™ does not degrade over time, so the beads will continue to be visible at follow up.
9. What literature regarding LC Bead LUMI™ is available? Duran 2015, Theranostics. 2016; 6(1):28-39 “A Novel Inherently Radiopaque Bead for Transarterial Embolization to Treat Liver Cancer – A Pre-clinical Study“ 10. What safety data is available on the use of LC Bead LUMI™? LC Bead LUMI™ has been cleared by the FDA based on substantial equivalence to LC Bead®. Furthermore, ISO studies and preclinical 90 day hepatic swine safety studies have been conducted with LC Bead LUMI™ The results of those studies showed: