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

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01994369
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
6
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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
Phase 1

Study Design

Study Type:
Interventional
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 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 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 Names:
  • 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. [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 [Day 1- Day 30]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    4. "People who would be easily lost to follow up (ex: People who are homeless or alcohol dependent)

    5. Patients unable to participate in the consent process (children and neonates).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None 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
    Other Study ID Numbers:
    • 818065
    • 818065 [UPenn IRB Protocol#]
    First Posted:
    Nov 25, 2013
    Last Update Posted:
    Jul 3, 2018
    Last Verified:
    Jun 1, 2018
    Keywords provided by Sunil Singhall, Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory, University of Pennsylvania
    Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 3, 2018