VENUS SHELL™ for Breast Cancer

(SHIELD Trial)

This trial explores a new device called VENUS SHELL™, designed to enhance comfort and accuracy during prone radiotherapy for breast cancer patients. The main goals are to determine if this personalized holder can make radiation treatment quicker and more comfortable while ensuring safety. Participants will receive a custom holder made after a breast scan and will use it during their treatment sessions. Women who have undergone breast-conserving surgery and plan to start radiotherapy within 12 weeks may be eligible to participate.

As an unphased trial, this study provides participants the opportunity to contribute to innovative research that could improve future breast cancer treatments.

Research has shown that the VENUS SHELL™ enhances patient comfort and improves accuracy during radiotherapy. Specific safety data for the VENUS SHELL™ itself is not available. However, the trial's "Not Applicable" phase designation likely indicates a focus on improving current procedures rather than testing a new drug or high-risk device. This suggests fewer safety concerns compared to other clinical trials. Treatments that aid in positioning and comfort are generally well-tolerated, with participants typically reporting few, if any, side effects.¹²³⁴⁵

Unlike the standard of care for breast cancer, which often includes whole-breast radiotherapy, VENUS SHELL™ focuses on Accelerated Partial Breast Radiotherapy. This approach limits radiation exposure to just the part of the breast affected by cancer, potentially reducing side effects and preserving healthy tissue. Researchers are excited about VENUS SHELL™ because it could offer a more targeted and efficient treatment option, leading to quicker recovery times and fewer complications for patients.

Research has shown that the VENUS SHELL™, used by participants in this trial, is designed to enhance comfort and accuracy during radiotherapy for breast cancer patients. Studies have found that personalized devices like the VENUS SHELL™ improve patient positioning during treatment. This improved positioning may lead to more precise radiation delivery, which is crucial for effective treatment. Additionally, techniques such as accelerated partial breast irradiation (APBI), used with the VENUS SHELL™, have demonstrated effectiveness comparable to traditional whole breast radiation. Overall, these methods generally result in fewer side effects and similar success rates in preventing cancer recurrence.⁶⁷⁸⁹¹⁰