A double blind, multi-centric, randomized controlled clinical trial to evaluate the efficacy and safety of VRP-1620 in increasing the sensitivity of sonomammography and lateral chest X-ray in patients of breast cancer.

Primary objective of the study is to evaluate the efficacy of VRP 1620 in increasing the sensitivity of sonomammography and lateral chest X-ray in the detection of solid breast tumors as evidenced by the change in positive predictive value (PPV) of each investigative modality.

A total of 220 subjects who will meet all the inclusion exclusion criteria as mentioned in this protocol will be recruited at various clinical trial sites within India.

Pharmacological agents that specifically increase tumor blood flow could be utilized to promote delivery of anticancer drugs and cancer detection contrast media to the site of tumors via blood stream. It is therefore imperative to identify new agents that can selectively modify tumor blood flow for therapeutic and diagnostic benefits. Tumor-infiltrating blood vessels deviate morphologically and biochemically from normal vessels, raising the prospect of selective pharmacological targeting Primary human tumors and xeno grafted tumors contain a sizeable fraction of immature blood vessels that do not have periendothelial coverage. Blood
vessels in the growing part of tumors lack smooth muscle covering and a fraction of endothelial cells in tumor vessels proliferate rapidly. Stimulation of endothelin B receptors located on the endothelial cells dilate tumor blood vessels and increase blood perfusion to the tumor. A selective increase in tumor blood perfusion can enhance delivery of chemotherapeutic or diagnostic contrast media to tumor tissue. It has been reported that endothelin receptors are over expressed in tumor tissues and cell lines. VRP1620 is the most widely used selective agonists for characterizing ETB receptors.  VRP 1620 is a linear analogue of endothelin 1 with 120000 folds selectivity towards ETB receptors compared to ETA receptors.