NCT01626066

Cathepsin Activatable Fluorescent Probe

A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: David Kirsch · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal.

Conditions

• Sarcoma
• Soft Tissue Sarcoma
• Breast Cancer

Interventions

Type	Name	Description
DRUG	LUM015	LUM015 assigned dose given once by IV push

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-08-01
• Completion: 2015-08-01
• First posted: 2012-06-22
• Last updated: 2015-12-09

Locations

1 site across 1 country: United States