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International Journal of Bioprinting                             Biocompatible 3D-printed radiotherapy spacer




            Table 2. Dosimetric parameters of the original phantom and phantoms using with pre-foam spacer and post-foam spacer.
             Structure       Parameter      Original phantom  Phantom with pre-foam spacer   Phantom with post-foam spacer
                              Max dose          36.5 Gy              36.0 Gy                  30.9 Gy
             Rectum
                             Mean dose          8.67 Gy              8.29 Gy                  6.66 Gy
                             Mean dose          71.9 Gy              71.7 Gy                  71.7 Gy
             Prostate
                               D                70.0 Gy              70.0 Gy                  70.0 Gy
                                 95%
            Abbreviation: D , dose covering 95% of the volume.
                       95%

            were not identical, it was not possible for the dosimetric   cancer treatment. To our knowledge, this is the first study
            parameters in the rectum to be the same. After inserting   to develop a medical device suitable for in vivo application
            the pre-foam spacer, although the distance between the   using MCP, which has not been used in existing medical
            rectum and prostate increased, the mean and maximum   technologies. During the spacer placement procedure
            doses in the rectum also increased owing to the influence   conducted before IMRT, the sterilized and foamed PCL
            of air. This limitation of this study indicates the need for   spacer was expanded in the batch chamber and positioned
            further research using more sophisticated phantoms and   correctly to increase the distance between the prostate and
            animal experiments.                                rectum. This method has the advantage of minimizing the
                                                               side effects and drawbacks of existing spacers. However,
               Comparing the results before and after the expansion of
            the spacer, it is clear that the distance between the prostate   the focus of this  research was  on the development and
                                                               feasibility of spacer products, and not translating them
            and rectum significantly increased. For the prostate, the   into clinical applications. Therefore, additional validation
            results were normalized, indicating that the mean dose   experiments are warranted before clinical applications. By
            and D 95%  remained nearly consistent. For the rectum, the   using 3D printing and MCP techniques, we developed a
            maximum dose was below 50 Gy in all three scenarios,   spacer for prostate cancer RT. By measuring DVH indices
            with  V 50Gy  and  V 70Gy  values being zero. The analysis of   in the rectum, we demonstrated that the spacer created
            the rectum showed that the maximum dose decreased   had sufficient clinical applicability; however, future clinical
            by approximately 15.3% and the mean dose decreased by   studies are required to validate its efficacy. Additionally, the
            19.7%. This clearly demonstrated the efficacy of the spacer   biodegradation time of PCL can be adjusted based on the
            developed in this study in reducing the dose delivered to   internal cell size and density, allowing it to remain in the
            the rectum. Additionally, a larger planning target volume   body as needed. Therefore, future research should focus on
            (PTV) for the prostate or the use of SBRT is expected to   selecting MCP conditions that can control cell size, thereby
            further enhance the dose-reduction effect. 32,37  However, a   adjusting the duration that PCL can remain in the body.
            potential disadvantage of the post-foam spacer is that after   Moreover, research efforts will also be directed to exploring
            expansion, its density is 0.12 g/cm³, which could introduce   the construction of 4D-printed spacers that can expand
            uncertainty in dose calculation.
                                                               upon body temperature changes to increase the distance
               The developed spacer reduced radiation exposure to   between the prostate and rectum, in order to replace the
            the rectum compared to when no spacer was used, which   conventional method of inserting a foamed spacer. Such
            could potentially reduce radiation toxicity as a result of RT   4D-printed spacers also will be validated using RT.
            for prostate cancer. However, this was a feasibility study
            using a phantom, and further research involving small   Acknowledgments
            animal experiments and additional studies are needed for   Graphical  abstract  was  created  with  BioRender.com
            validating its application in clinical setting.
                                                               (agreement number VE276LCQ20).
            4. Conclusion
                                                               Funding
            In this study, a completely new type of spacer that can
            replace the existing spacers was developed. Using 3D   This work was supported by National Research Foundation
            printing of biocompatible PCL resin with scCO  for   of Korea (NRF) grants funded by the Ministry of
                                                      2
            sterilization and gas absorption, we developed a customized   Education (RS-2023-00247348).
            product that integrates all the advantages of current   Conflict of interest
            spacers. This study aimed to minimize radiation exposure
            to the organ at rick (rectum) during IMRT for prostate   The authors declare they have no competing interests.


            Volume 10 Issue 5 (2024)                       484                                doi: 10.36922/ijb.4252
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