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

NCT ID: NCT01994369

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EC17

Intervention Type: DRUG

Interventions

EC17

Intervention Type: DRUG

Other Intervention Names

Folate-FITC

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Sunil Singhall

Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunil Singhal, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

818065 [UPenn IRB Protocol#]

Identifier Type: -

Identifier Source: secondary_id

818065

Identifier Type: -

Identifier Source: org_study_id