Bethel Park

Researchers are evaluating whether adding biennial contrast-enhanced mammography CEM to annual 3D mammography digital breast tomosynthesis or DBT improves breast cancer detection while keeping false positives low in women with a personal history of breast cancer. The study aims to see if CEM can maintain or improve cancer detection rates compared to annual DBT alone, potentially finding cancers missed by DBT. This trial is prospective and involves women aged 30 to 79 who have had breast cancer and are at least one year past surgery or treatment. Participants will receive a baseline CEM exam along with their routine annual 3D mammogram, then have follow-up CEM exams at 24 and 48 months after the baseline. Throughout the study, they will continue their usual annual 3D mammograms as part of standard care. Two radiologists will independently review the mammograms and CEM images in different sequences to evaluate detection rates and false positives. During the study, women will attend screening visits to receive their imaging exams and have their results interpreted by radiologists. Researchers will measure how many additional cancers are detected at 24, 48, and 62 months, the rate of false-positive recalls, and the positive predictive value of the combined imaging. The study will monitor participant safety and outcomes over several years, with the total participation lasting at least four years.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.