Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Sunil Singhall, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01994369
First received: November 19, 2013
Last updated: June 17, 2014
Last verified: June 2014

November 19, 2013
June 17, 2014
May 2014
November 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01994369 on ClinicalTrials.gov Archive Site
The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1- Day 30 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)
A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Surgery Presenting Breast Cancer

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Resectable Breast Cancer
Drug: EC17
Other Name: Folate-FITC
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.
Intervention: Drug: EC17
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adult patients 18 years of age and older
  2. Patients presenting with breast cancer presumed to be resectable by lumpectomy and/or mastectomy on pre-operative assessment
  3. Good operative candidate
  4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

  1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
  2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
  3. At-risk patient populations

    1. "People who would be easily lost to follow up (ex: People who are homeless or alcohol dependent)
    2. Patients unable to participate in the consent process (children and neonates).
Both
18 Years and older
No
Contact: Sunil Singhal, M.D. sunil.singhal@uphs.upenn.edu
United States
 
NCT01994369
818065, 818065 [UPenn IRB Protocol#]
Yes
Sunil Singhall, University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Sunil Singhal, M.D. University of Pennsylvania
University of Pennsylvania
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP