Preclinical and clinical studies on lymph node imaging using perflubron emulsion.
A perflubron emulsion is being developed as a contrast agent to enhance lymph nodes on computed tomography (CT) images. The emulsion is administered by percutaneous injection into the drainage field of the lymph nodes to be imaged. A series of preclinical studies was conducted to investigate the efficacy of the perflubron emulsion for enhancement of lymph nodes on CT images. The effects of dose (0.10 to 0.50 mL), application of massage, and route of administration were investigated in healthy New Zealand white rabbits. Results of these studies demonstrated that doses as low as 0.15 mL were efficacious for consistent enhancement of axillary lymph nodes on CT images after subcutaneous injections in the forepaw. Application of massage to the injection site decreased the time for maximum nodal enhancement from approximately 7 days to 2 days postinjection. A pilot study conducted in 18 healthy, male volunteers indicated dose-related enhancement of axillary lymph nodes on CT images following subcutaneous injections of the emulsion in the hand. Other than mild, transient injection-site discomfort, no clinically significant side effects were observed. These data demonstrate that the perflubron emulsion is safe and can enhance axillary lymph nodes on CT images following injections in the hand.
Alliance Pharmaceutical Corp., San Diego, CA 92121.
G
G
Hanna
D
D
Saewert
J
J
Shorr
K
K
Flaim
P
P
Leese
M
M
Kopperman
G
G
Wolf
D000704:Analysis of Variance; D000818:Animals; D003287:Contrast Media / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004333:Drug Administration Routes; D004353:Drug Evaluation, Preclinical; D004655:Emulsions; D005069:Evaluation Studies as Topic; D005466:Fluorocarbons / Q000009:adverse effects; D006801:Humans; D006842:Hydrocarbons, Brominated; D008198:Lymph Nodes / Q000000981:diagnostic imaging*; D008297:Male; D008405:Massage; D010865:Pilot Projects; D011817:Rabbits; D014057:Tomography, X-Ray Computed
D003287:Contrast Media; D004655:Emulsions; D005466:Fluorocarbons; D006842:Hydrocarbons, Brominated; C003072:perflubron