NCT03286062

VM110 in Detection of Microscopic Tumors: A Phase I Study

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Ovarian Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Agent VM110 and laproscopic infra-red probe	Patients with evidence of persistent or recurrent ovarian/ pancreatic cancer would be injected with escalating dose of VM110 24 hr prior to laproscopic surgery to collect biopsy sample in white light and by visualizing the cancerous mass using the laproscopic infra red probe

Timeline

• Start date: 2017-10-12
• Primary completion: 2019-07-10
• Completion: 2020-04-03
• First posted: 2017-09-18
• Last updated: 2020-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study