Potential for improvement in clinical decision-making: tumor imaging with in-111 labeled liposomes results of a phase ii-iii study

Abstract

Liposome scanning using In- 111 labeled VS102 liposomes (VesCan^R) has previously been shown to image a wide variety of common human tumors, probably related to tumor neovascular capIIIary fenestrations and binding of liposomes to tumor cells. We further tested In-III VS102 liposomes in a Phase II trial (27 patients) and a Phase III trial (38 patients). The sensitivity for detecting tumors in primary sites was 82% and in metastatic sites was 65% at the recommended lipid dose of 100 mg. There was 1 false positive scan (specificity 98%). Tumors which have been imaged include carcinomas of the breast, lung, head-neck, prostate, colon, ovary, cervix, thyroid, kidney, testes, melanoma, sarcoma and lymphoma. Sites imaged have included soft tissue, breast, mediastinum, bone, lung, lymph node, liver and pelvis. We also describe five patients in whom a In-111 liposome scan was performed in addition to standard tests, and in whom therapy plans were changed by use of liposome scan results. In two instances, no therapy would have been given without In-III liposome scan, but chemotherapy or radiotherapy were used based on liposome scan results and confirmatory tests. In one patient, surgery would have been used in the absence of In-III liposome scans, versus radiotherapy with In-III liposome scan results. In two other patients, palliative radiotherapy or chemotherapy would have been given without In-111 liposome scan. One of the patients would have required further therapy and the other needed curative surgery after liposome scan evaluation. These results suggest In-111 liposome scans may be useful to complement standard diagnostic tests in cancer patient management.