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

This study is currently recruiting participants.
Verified November 2013 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: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Resectable Triple Negative Breast Cancer
Drug: EC17
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The number of participants that will have an adverse reaction to the EC17 [ Time Frame: Day 1- Day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients 18 years of age and older
  2. Patients presenting with a triple negative 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01994369

Contacts
Contact: Sunil Singhal, M.D. sunil.singhal@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Sunil Singhal, M.D. University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Sunil Singhall, Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01994369     History of Changes
Other Study ID Numbers: 818065, 818065 [UPenn IRB Protocol#]
Study First Received: November 19, 2013
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Triple Negative Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Folic Acid
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014