Clinical Trials with a New Iodinated Lipid Emulsion for Computed Tomography of the Liver

Abstract

A new iodinated lipid emulsion, Intraiodol, for which animal studies have indicated better tolerance than for other iodinated lipid emulsions, was tested in 15 patients with malignant lesions, and in one patient with focal nodular hyperplasia. Repeated CT scans of the liver and spleen and blood tests were performed for 24 hours after intravenous injection of Intraiodol. The uptake of Intraiodol in the liver (peak mean 28.6 HU) was higher than in the spleen (peak mean 21.8 HU). The uptake of Intraiodol in malignant lesions was minimal (peak mean 2.8 HU). The detection rate of hepatic lesions was equal to or better than that achieved by US, CT, and/or CT angiography. However, liver uptake of Intraiodol was low in 2 patients with severe fatty infiltration. Intraiodol produced vascular enhancement up to one hour after injection since it was eliminated slowly from the circulation. The observed adverse reactions consisted of temporary metallic taste in 5 of the patients, fever and exacerbation of back pain in one patient, and transient thrombocytopenia in one patient. Alkaline phosphatase increased (17%, p<0.01) only at two hours, and erythrocyte count (6%, p<0.05) at 24 hours after injection. Our initial results indicate diagnostic advantages of Intraiodol without serious adverse reactions. Further clinical studies are required to confirm these findings.