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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Surgery Presenting Breast Cancer

Conditions
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Resectable Breast Cancer

Intervention / Treatment
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* Drug: EC17


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EC17 Injection group<br>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<br> <br> * Other names: Folate-FITC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants that will have an adverse reaction to the EC17 |  | Day 1- Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer