PRECLINICAL AND CLINICAL-STUDIES ON LYMPH-NODE IMAGING USING PERFLUBRON EMULSION

A perflubron emulsion is being developed as a contrast agent to enhanc e lymph nodes on computed tomography (CT) images. The emulsion is admi nistered by percutaneous injection into the drainage field of the lymp h nodes to be imaged. A series of preclinical studies was conducted to investigate the efficacy of the perflubron emulsion for enhancement o f lymph nodes on CT images. The effects of dose (0.10 to 0.50 mL), app lication of massage, and route of administration were investigated in healthy New Zealand white rabbits. Results of these studies demonstrat ed that doses as low as 0.15 mL were efficacious for consistent enhanc ement of axillary lymph nodes on CT images after subcutaneous injectio ns in the forepaw. Application of massage to the injection site decrea sed the time for maximum nodal enhancement from approximately 7 days t o 2 days postinjection. A pilot study conducted in 18 healthy, male vo lunteers indicated dose-related enhancement of axillary lymph nodes on CT images following subcutaneous injections of the emulsion in the ha nd. Other than mild transient injection-site discomfort, no clinically significant side effects were observed. These data demonstrate that t he perflubron emulsion is safe and can enhance axillary lymph nodes on CT images following injections in the hand.