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

NCT01994369 | Completed Phase 1 DMC

• 2 other identifiers: 818065818065 [UPenn IRB Protocol#]
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• The number of participants that will have an adverse reaction to the EC17

  Day 1- Day 30

Study Arms (1)

EC17 Injection group

EXPERIMENTAL

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

Interventions

EC17 DRUG

Also known as: Folate-FITC

EC17 Injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
• Patients with a history of anaphylactic reactions to Folate-FITC or insects
• At-risk patient populations
• "People who would be easily lost to follow up (ex: People who are homeless or alcohol dependent)
• Patients unable to participate in the consent process (children and neonates).

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sunil Singhal, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 3, 2018

Record last verified: 2018-06

Locations

US (1)