8 June 2020

The following concluding evaluations of BioXmark^®, Nanovi’s liquid fiducial marker, have been published from the study:

Visibility on imaging and excellent positional stability

Good MRI visibility

Fast and easy endoscopic injection procedure

DK-Copenhagen, 3 June 2020 – Nanovi informs that a published prospective study by the Amsterdam UMC, a leading university hospital in Amsterdam, the Netherlands, evaluated the technical feasibility and clinical performance of BioXmark^® in a cohort of patients with esophageal cancers eligible for Image-Guided Radiation Therapy, IGRT.

BioXmark^® is a liquid fiducial marker, developed by Nanovi to enhance target visibility on imaging and enable high precision radiation therapy across cancer indications.

Study introduction

The publication introduces the study as follows:

“Radiation Therapy (RT) with concurrent chemotherapy plays a significant role in the treatment of patients with operable or inoperable esophageal cancers. Modern radiation delivery techniques can deliver radiation dose with high precision to the target. Subsequently, accurate delineation and subsequent accurate (patient) setup verification becomes more important.”

“RT in patients with esophageal cancer can still be optimized by more precise target definition and daily dose delivery with image guided RT (IGRT). Therefore, an easily applicable marker with good visibility on different imaging modalities and positional stability becomes more vital.”

Study design

The study first analyzed the visibility of BioXmark^® ex vivo in porcine tissue on different imaging modalities. Next, BioXmark^® markers were injected under endoscopic ultrasound guidance in 10 patients with curable esophageal cancers, and the technical feasibility of the injection procedure and the clinical performance of the markers was evaluated. A total of 24 markers were placed in the clinical part of the study.

Study conclusions and discussions

It was concluded in the publication that injection of a novel liquid fiducial marker (i.e. BioXmark^®) for esophageal cancer RT is technically feasible with no adverse events identified.

Further, it was evaluated that BioXmark^® marker volumes of > 0.05 ml have an appropriate visibility on CT, CBCT and MRI with an excellent positional stability, and that a liquid fiducial marker therefore is promising for use in IGRT.

The publication further concludes that the clear visibility of BioXmark^® on MRI opens a new area of possibilities for MRI-guided delineation or registration. It is suggested that MRI-based esophageal delineation is feasible, and that DW-MRI might have complementary value in delineation. Also, for IGRT setup on an MRI-based linear accelerator, good MRI visibility of fiducial markers is of greatest interest.

In terms of application of a fiducial marker, the publication discusses that the largest advantage of BioXmark^® over the gold fiducial markers is not the clinical performance during IGRT, which is also good with gold fiducial markers, but the easier and faster endoscopic injection procedure, especially when multiple markers are needed.

Reference to the publication:

Machiels M., Voncken F. E. M., Jin P., van Dieren J. M., Bartels-Rutten A., Alderliesten T., Aleman B. M. P., van Hooft J. E., Hulshof M. C. C. M.  A Novel Liquid Fiducial Marker in Esophageal Cancer Image Guided Radiation Therapy: Technical Feasibility and Visibility on Imaging. July 2019, Practical Radiation Oncology 9(6), pages 506-515.

Link to the publication:

https://www.practicalradonc.org/article/S1879-8500(19)30189-4/fulltext

Nanovi contact:

Jesper Boysen, CEO

Phone:              +45 24 65 60 33

E-mail:                [email protected]

Download the full press release here: