13 June 2022

• A clinical study from Amsterdam University presented at ESTRO 2022, showed that 94% of BioXmark® markers were placed correctly and remained present at the last CBCT scan versus 62% for a gold marker comparator
• Visibility and benefit of fiducial markers, including BioXmark®, in IGRT of stomach cancer will be evaluated in an ongoing study

Nanovi informs that in a clinical study, its liquid fiducial marker, BioXmark®, has shown to be technically feasible to implant in stomach cancer patients to guide pre-operative image-guided radiation therapy (IGRT). During pre-operative IGRT of the stomach, it can be challenging to adequately identify the treatment target on daily acquired CBCT scans.

This clinical study from the Amsterdam University Medical Center included twelve (12) stomach cancer patients. The aim of the study was to assess the technical feasibility of gold marker (Visicoil) and liquid marker (BioXmark®) implantation for use to guide pre-operative stomach cancer IGRT. A marker was evaluated as technically feasible and successful if 1) its implantation was assessed as successful, 2) it was present on the first scan post-implantation, 3) it was present on the last fraction’s CBCT and 4) its placement was adequate (i.e., in or near the stomach wall) or if no marker migration occurred.

All 12 patients in the study received gold markers (0.35mm x 10mm) and 7 of these patients also received BioXmark® (injection volumes of 0.08-0.20 ml). 5-8 markers were intended implanted in the stomach of each patient. The gold markers were individually backloaded into a 22-gauge endoscopic needle prior to each gold marker placement. BioXmark® (1 ml) was loaded once per patient in a 25-gauge injection needle, which allowed for the placement of multiple subsequent markers without retraction of the needle.

Study results and conclusion

There were no procedure-related complications, and of 79 markers intended to be implanted, 68 were assessed to be implanted successfully. None of the non-successful implantations were related to BioXmark®. At the last CBCT scan, 17 of 18 (94%) BioXmark® markers remained visible and were placed correctly versus 38 of 61 (62%) for the gold marker. No marker migration was observed.

 

It was concluded that fiducial marker placement in the stomach was technically feasible and successful.

 

The visibility and benefit of fiducial markers in IGRT (using 4DCT and 4DCBCT) will be evaluated in an ongoing study.

 

Reference

Bleeker M, Pouw R, Bel A, Sonke JJ, Hulshof M, Horst A van der. Feasibility of endoscopic fiducial marker implantation in the stomach for use in image-guided RT [Internet]. 2022 [cited 2022 Apr 28]. Available from: https://www.estro.org/Congresses/ESTRO-2022/652/uppergi/10919/feasibilityofendoscopicfiducialmarkerimplantationi

 

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See our White Paper for more information on BioXmark to guide RT of stomach and esophageal cancers.