Early Feasibility Clinical Investigation Using a Novel 90-Yttrium-based Internal Radiotherapy Platform, YntraDose1 in Unresectable Locally Advanced Pancreatic Adenocarcinoma as an Add-on to First-line Chemotherapy

What this Trial Is About

Researchers are evaluating a new type of radiotherapy called YntraDose1, which uses Yttrium-90 microspheres injected directly into pancreatic tumors. This study focuses on patients with unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) who cannot have surgery. The main goals are to assess the safety and tolerability of YntraDose1 combined with standard chemotherapy, the feasibility of injecting the device into tumors, the treatment's impact on quality of life and pain, and how the tumor responds over three months. YntraDose1 is a single-use medical device delivered percutaneously under ultrasound or CT guidance directly into the tumor. Participants will receive standard chemotherapy initially, which is paused after two months to reassess the tumor. The radioactive implant is then administered between chemotherapy sessions. After the treatment, chemotherapy resumes. The study lasts about seven months, with participants visiting the clinic eight times, including a two-night hospital stay for treatment and safety monitoring. During the study, participants will complete questionnaires about their daily life and pain levels. They will undergo imaging scans such as CT and MRI to monitor tumor response. Blood and urine tests will be taken to check safety. The primary outcomes measured include safety, tolerability, and feasibility of device administration, while secondary outcomes focus on quality of life, pain, and tumor response over a three-month follow-up period.

Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC