Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging

What this Trial Is About

Researchers are evaluating a new ultrasound imaging technique called Contrast Enhanced Super-Resolution (CESR) imaging to study known lesions in the breast, liver, and kidney. This Phase 2 study includes 40 participants divided into four groups: 10 healthy volunteers for system optimization, and 30 patients with lesions in the breast, liver, or kidney based on prior imaging and scheduled for biopsy. The study aims to assess how well CESR imaging detects and differentiates between malignant and benign lesions compared to traditional ultrasound and pathological findings. Participants will receive an intravenous injection of the contrast agent perflutren lipid during imaging. The study uses both CESR and conventional B-mode ultrasound, with the latter performed immediately beforehand to locate the lesions. Imaging parameters will be optimized in healthy volunteers using the new ultrasound system. Patients with lesions in the breast, liver, or kidney will be imaged using CESR to evaluate the lesions. During the study, participants will be monitored for any reactions to the contrast agent for 15 minutes following administration. Researchers will compare CESR imaging results with biopsy findings to measure sensitivity and specificity for each organ. The study involves a single center and is non-randomized. Participation includes imaging procedures guided by conventional ultrasound and contrast administration, with outcome measures focused on diagnostic accuracy and comparison with standard ultrasound. The study is expected to continue until December 2028.

Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging