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 ofbreast cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 14
- 主要终点
- tumors as evidenced by the change in positive predictive value PPV of each investigative modality
研究概览
简要总结
Study Title
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
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.
Secondary Objective To assess the safety of VRP-1620 post administration Study Duration Approximately 10 days including screening, randomization, biopsy and follow up visit Study Population & Size
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.
Study Background
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female subjects in the age group of 18-65 years Subjects presenting for routine breast cancer examination Subjects with suspected clinical diagnosis of breast cancer Subjects who have not undergone any biopsy for breast cancer Subjects willing to give written informed consent.
排除标准
- •Subjects with coagulopathy history of stroke deep vein thrombosis cardiac dysfunction uncontrolled hypertension history of cardiac surgery brain tumor or brain metastasis, and sarcomas Subject with respiratory disorder Pregnancy or lactation Subject has undergone a breast augmentation or breast implant Subject has significant existing breast trauma Subjects with abnormal renal & liver functions Subjects allergic to VRP-1620 and related products A marked baseline prolongation of QT/QTc interval eg repeated demonstration of a QTc interval grater then 450 milliseconds (ms) A history of additional risk factors for TdP eg heart failure, hypokalemia, family history of Long QT Syndrome) The use of concomitant medications that prolong the QT or QTc interval.
- •Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.
结局指标
主要结局
tumors as evidenced by the change in positive predictive value PPV of each investigative modality
时间窗: Approximately 10 days
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
时间窗: Approximately 10 days
次要结局
- To assess the safety of VRP 1620 post administration(Approximately 10 days)