Prospective Multicenter Evaluation of Patient Satisfaction and Radiologist Image Interpretation Using the Envision™...

Improving image quality without increasing patient discomfort remains a challenge in mammography. This study evaluated the ability of the Envision™ platform in a prospective, multicenter observational case-collection study (NCT05199701), focusing on patient comfort and radiologist-assessed image quality.

Across nine US breast-imaging sites, 929 women aged ≥35 years undergoing a clinically indicated screening or diagnostic mammogram, or a mammogram in the context of a recommended biopsy, were enrolled. All subjects received a standard four-view bilateral exam (RCC, RMLO, LCC, LMLO) on the Envision platform. Radiologists rated image quality (positioning, contrast, sharpness, tissue visibility, noise, artifacts, and overall clinical image quality) using a three-category scale (requires reimaging, acceptable, excellent). Patient comfort and device preference were assessed via questionnaire. Analyses were descriptive.

Most subjects (79%) preferred the investigational mammogram over prior mammograms, and 70% reported greater compression comfort. Discomfort scores were low: 34% reported no discomfort (0/10) and 52.5% reported minimal discomfort (1-2/10). Radiologists rated the majority of images acceptable or excellent, with excellent ratings of 41.9-48.5% for contrast, 41.8-42.0% for sharpness, 50.2-50.5% for tissue visibility, and 33.4-34.5% for artifacts. Repeat-imaging recommendations were infrequent (0-6.6% across views), and overall clinical image quality was acceptable or excellent in 94.1-100% of images.

The Envision platform produced consistently high levels of clinically acceptable image quality while maintaining or improving patient comfort compared to prior mammography experiences. These findings support its feasibility for routine clinical use.