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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Resectable Breast Cancer	Drug: EC17	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: EC17; Other Name: Folate-FITC

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1- Day 30 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

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

More Information

• Responsible Party: Sunil Singhall, Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01994369
• Other Study ID Numbers: 818065; 818065 [UPenn IRB Protocol#]
• First Posted: November 25, 2013
• Last Update Posted: July 3, 2018
• Last Verified: June 2018

Keywords provided by Sunil Singhall, University of Pennsylvania:

Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases