Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01994369|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : July 3, 2018
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 year. 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.
There is an over expression of folate receptors located on the surface of many human carcinoma nodules.Specifically for breast cancer up to 33% of all breast cancers over express the folate receptor.
Folate-fluorescein isothiocyanate, or folate-FITC, also identified as EC-17, targets folate receptors over expressed in certain cancers such as breast cancer, and could help in better identifying the margins of the cancer thereby achieving negative margins.
|Condition or disease||Intervention/treatment||Phase|
|Resectable Breast Cancer||Drug: EC17||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Surgery Presenting Breast Cancer|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
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
- The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration. [ Time Frame: Within two to four hours of injection of EC17 ]
- The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1- Day 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994369
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Sunil Singhal, M.D.||University of Pennsylvania|