VM110 in Detection of Microscopic Tumors: A Phase I Study

Ovarian Cancer Clinical Trial

Official title: VM110 in Detection of Microscopic Tumors: A Phase I Study

Status Terminated

Clinical Trial Summary

A laproscopic imaging tecgnology that uses a synthetic agent to detect ovarian and pancreatic cancers at an early stage so that patients can get treatment early and prevent the disease from advancing to late stage leading to fatality or recurrence.

Clinical Trial Description

Current methods of imaging techniques, CT, MRI and PET, fail to detect moderate volume of diffuse intraperitoneal tumor and provide limited functional information. White light laproscopy is capable of detecting small volume disease in only half of patients in clinical remission, missing occult disease in 30% of this patient population. In this study, a synthetic agent VM110 is to be tested for its ability to detect occult ovarian and pancreatic cancers. The agent is cleaved by proteases, cathepsin B, L, and S and plasmin in cancer cells and the fluorescent cleavage product is detected by near infra red imaging probe. High sensitivity of visualizaion of cancer cells can help detect sub-clinical disease otherwise unidentifiable by usual methods.

Primary Objectives

1. To investigate the safety and toxicity of escalating doses of VM110 administered IV prior to laparoscopic surgery.

2. To define the appropriate dose of VM110 for use in future trials.

3. To define the preliminary efficacy: the optimal dose of VM110 in detection of microscopic peritoneal tumor at laparoscopy not visible with standard white light laparoscopy. Areas visible with both standard white light and NIRF light, and areas visible only with NIRF light will be biopsied. Data from pathologic evaluation of these specimens will be used to determine the efficacy of VM110 with respect to its ability to detect occult disease not visible with standard white light

Secondary Objectives

1. Estimate sensitivity and specificity of VM110 detection

2. Perform correlative pharmacologic and histopathological analyses ;

Related Conditions & MeSH terms

• Ovarian Cancer
• Pancreatic Cancer

• NCT number: NCT03286062
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Status: Terminated
• Phase: Phase 1
• Start date: October 12, 2017
• Completion date: April 3, 2020