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

• ClinicalTrials.gov Identifier: NCT01994369
• Recruitment Status: Completed
• First Posted: November 25, 2013
• Last Update Posted: July 3, 2018
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): Sunil Singhall, University of Pennsylvania

Tracking Information

• First Submitted Date: November 19, 2013
• First Posted Date: November 25, 2013
• Last Update Posted Date: July 3, 2018
• Study Start Date: May 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 17, 2014): 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 ]
• Original Primary Outcome Measures (submitted: November 19, 2013): 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 ]
• Current Secondary Outcome Measures (submitted: November 19, 2013): The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1- Day 30 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)
• Official Title: A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Surgery Presenting Breast Cancer

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Resectable Breast Cancer

Intervention

Drug: EC17

Other Name: Folate-FITC

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 19, 2013): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01994369
• Other Study ID Numbers: 818065; 818065 [UPenn IRB Protocol#]
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sunil Singhall, University of Pennsylvania
• Study Sponsor: University of Pennsylvania
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sunil Singhal, M.D.; University of Pennsylvania

• PRS Account: University of Pennsylvania
• Verification Date: June 2018