Pilot Study of Implantable Microdevice for Drug Testing in Salivary and Head and Neck Cancers During Surgery

What this Trial Is About

Researchers are evaluating the safety and feasibility of an implantable microdevice IMD to measure local tumor responses to multiple drugs in patients with untreated head and neck cancers, including salivary gland cancers and squamous cell carcinoma. This early-phase pilot study focuses on placing the microdevice into tumors before surgical removal to understand which drugs may be effective for treating these cancers. The study is supported by a research foundation and is the first to test this device in these cancer types. Participants will have the IMD placed into their tumors using image-guided procedures. The device contains up to 20 drugs or drug combinations, which are released locally over 3 to 5 days before surgical removal of the tumor and device. After surgery, participants receive standard adjuvant cancer treatments. Tumor tissue and the device will be analyzed to assess drug responses and molecular changes. During the study, participants will undergo imaging, laboratory tests, and surgery with microdevice placement and removal. Researchers will monitor treatment-related toxicities 7 to 14 days after surgery and follow tumor response, gene expression, metabolism, and biomarkers for about one year. The study involves about 30 participants and aims to gather data on safety, drug effectiveness signals, and molecular effects to guide future treatments for head and neck cancers.

Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers