Next-Generation Tethered Capsule Endomicroscopy Platform for Clinically and Commercially Viable Esophageal Cancer Screening
Abstract
The fiscal year 2022 (FY22) Peer Reviewed Cancer Research Program (PRCRP) Topic Area to be addressed by the proposed research is Esophageal Cancer. The FY22 PRCRP Military Health Focus Area(s) in Section II.A.2 to be addressed include environmental/exposure risk factors associated with cancer as well as gaps in cancer prevention, early detection/diagnosis, prognosis, and/or treatment. The scientific objective of this proposed project is to develop a low-cost disposable diagnostic tool that can be readily accessible at a primary care physician office and used as part of a routine physical exam. The technology currently exists as a reusable device that is light-based and could replace standard endoscopy as a diagnostic tool for identification of Esophageal Cancer and its precursor, Barrett s Esophagus. The light-based device is a swallowable capsule, approximately the size of a Tylenol capsule, but with a string-like attachment or tether from the capsule to the instrument running the diagnostic scanning. Currently, more than 550 people have participated in diagnostic studies with the tethered capsule; however, the swallowability rate of the current capsule is about 75%. Through development of a more flexible tether attachment and a simpler battery powered device, the expectation is that swallowability will increase to 95%. Increasing swallowability and decreasing cost will make this system more readily available to clinics and primary care offices, and will allow nurses, physician assistants, or doctors to conduct the procedure in their office as part of a routine physical exam. Because the capsule-based procedure does not require sedation, this becomes a more accessible procedure with limited patient inconvenience or preparation. This research is conducted in partnership with MGH Home Base, a program that has served more than 30,000 Veterans and their Family Members and trained over 85,000 clinicians across the nation. Home Base’s integrated team of professionals work together to ensure that Veterans, Service Members, and their Families receive or are connected to appropriate and uniquely tailored care. From our collaboration with Home Base, their current patient base includes Veterans from the Vietnam War and current Service Members whose diagnosis aligns with environmental factors that are precursors to Barrett s Esophagus. Home Base has seen an increase in cancer rates in their Veteran and active-duty patients and are interested in this partnership to develop a suite of screening tools that could be included as part of a primary care visit to identify precursors of cancer, such as Barrett s Esophagus, without requiring a more invasive, cumbersome, and costly upper endoscopy procedure. Pre-diagnostic capability gives active-duty Service Members the opportunity for treatment and avoidance of advancement to cancer, allowing a swifter return to work. The swallowability study is the first step to realizing a lower cost version of the current reusable OCT capsule. It is expected that, should this proposal be funded and successfully achieve the goals, the next steps would be transfer to industry that would commercialize the product and conduct larger scale pivotal clinical trials. The FY22 PRCRP Overarching Challenges to be studied in this proposal include Prevention, Diagnostics/Prognostics, and Disparity. Through Prevention, this disposable OCT device can be used in a primary care setting with a patient who does not need to be sedated or prepared clinically, allowing early identification of Barrett s Esophagus. Those who exhibit Barrett s Esophagus can be clinically evaluated for treatment with the goal of prevention of Esophageal Cancer. If indications are that Barrett s Esophagus is present, this swallowable device can also monitor further progression of the disease. Through Diagnostics/Prognostics, where primary care screenings will be conducted with this swallowable capsule diagnostic tool, treatme
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310694
Entities
People
- Guillermo Tearney
Organizations
- Massachusetts General Hospital
- United States Army