# Design and Development of a Device (Sifilotto®) for Tumour Tracking in Cervical Cancer Patients Undergoing Robotic Arm LINAC Stereotactic Body Radiation Therapy Boost: Background to the STARBACS Study

## TL;DR

A new 3D-printed device with gold fiducials was developed to track tumors in cervical cancer patients during non-invasive radiation therapy, avoiding the need for surgical implants.

## Contribution

The development of a non-invasive 3D-printed intravaginal device with embedded gold fiducials for tumor tracking during robotic LINAC stereotactic radiotherapy.

## Key findings

- The device was successfully tested in seven patients, demonstrating feasibility and reproducibility.
- The device eliminates the need for invasive fiducial marker implantation, improving patient comfort and workflow.
- The device design led to a utility model patent.

## Abstract

In the treatment of locally advanced cervical cancer, brachytherapy is often a crucial step after external beam radiation and concurrent chemo-immuno-radiation. However, when brachytherapy is not feasible due to patient or tumor-related challenges, delivering a precise external beam boost becomes necessary. Traditionally, this requires invasive implantation of fiducial markers to guide treatment when a robotic LINAC is used. To offer a non-invasive alternative, we developed a novel 3D-printed intravaginal device containing embedded gold fiducials for accurate tumor tracking during stereotactic radiotherapy with a robotic arm LINAC. This innovation eliminates the need for surgical procedures, improving patient comfort and workflow efficiency. This paper details the design and implementation process of the device, which led to a utility model patent.

Standard of Care (SOC) for locally advanced cervical cancer is represented by external beam radiation therapy concurrent with platinum-based chemotherapy and immunotherapy (cCIRT) followed by brachytherapy boost and immunotherapy maintenance. In some instances, it is impossible to perform brachytherapy due to patient and/or cancer issues. In these circumstances, an external beam boost could be delivered. Using a robotic arm LINAC, it is mandatory to use intramucosal implanted fiducials which are needed for tumour tracking. To avoid invasive procedures, we developed an original intravaginal 3D-printed universal device containing gold fiducials embedded within it. In this paper, we describe the step-by-step procedure that allowed us to obtain the utility model patent, including the in vivo test (feasibility, reproducibility, device compliance) on seven patients within the study protocol “STereotActic Radiotherapy Boost in locally Advanced Cervical carcinoma patientS” (STARBACS).