Bethel Park

Researchers are evaluating whether adding biennial contrast-enhanced mammography (CEM) to annual 3D digital breast tomosynthesis (DBT) improves breast cancer detection in women with a personal history of breast cancer. The study aims to see if this combination identifies more cancers while keeping false-positive rates low. The focus is on women aged 30 to 79 who are at least one year past breast cancer surgery or treatment and are undergoing routine annual mammograms with tomosynthesis. Participants will receive a baseline CEM exam alongside their routine DBT exam, followed by additional CEM exams at 24 and 48 months. They will continue annual DBT exams as part of standard care throughout the study. Two radiologists will independently review the DBT and CEM images in alternating order to compare cancer detection rates and false-positive findings between the two imaging methods. During the study, researchers will monitor the incremental cancer detection rate, false-positive recall rate, and positive predictive values at 24, 48, and 62 months. Participants will undergo imaging evaluations and routine mammograms, with detailed image interpretation by radiologists blinded to the other modality. The study will assess whether biennial CEM plus annual DBT provides better screening outcomes with acceptable safety and accuracy over more than five years of follow-up.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.