Intraoperative Imagery of Triple Negative Breast Cancer With Folate-FITC (EC17)
Breast cancer is the most common cancer and the second cause of cancer mortality in women. There are approximately 200,000 new cases of breast cancer a year1. Classically, breast cancers are divided into two groups, invasive and non-invasive. A mainstay of the treatment of both of these types is surgical resection not only for therapeutic purposes but also for diagnostic purposes. Breast conserving therapy includes surgical lumpectomy and post-operative radiation. However, despite best surgical practices, when patients undergo BCT anywhere from 20 - 40% of these patients have margins positive for cancer. This leads to increased rates of reoperation which are quoted to be as high as 30% and increased local recurrences.
The folate receptor located on these nodules is well known to be overexpressed on the surface of many human carcinomas. Specifically for breast cancer up to 33% of all breast cancers over express the receptor7. Also, breast cancers are also known to have specific hormone receptor profiles. Breast cancers can overexpress the estrogen, progesterone or epidermal growth factor cell surface receptors. Breast cancers that do not overexpress any of these receptors are called triple negative breast cancers (TNBC). These cancers that represent about 15% of all breast cancer have an aggressive phenotype and carry a poor prognosis. Also, greater than 80-90% of all TNBC's over express the folate receptor.
Folate-fluorescein isothiocyanate, or folate-FITC, also identified as EC-17, has been shown to be sensitive to folate receptors and therefore improve on negative margins. Because of its sensitivity, the drug is given at a low dose for diagnostic purpose only.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Surgery Presenting With Triple Negative Breast Cancer|
- The ability of the imaging system to detect the expression of EC17 in the nodule/mass (i.e. tumor) and discern the uptake of the dye by the tumor [ Time Frame: Within two hours of injection of EC17 ] [ Designated as safety issue: No ]
- The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1- Day 30 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2013|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: EC17 Injection group
This group with receive a single dose of EC17, infused over 10 minutes, prior to surgery. Then, during surgery, they will be imaged with a camera and an imaging probe the investigators have developed.
Other Name: Folate-FITC
|Contact: Sunil Singhal, M.D.||firstname.lastname@example.org|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Sunil Singhal, M.D.||University of Pennsylvania|