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

Phase 1

Completed

• Conditions: Resectable Breast Cancer
• Interventions: Drug: EC17

• Registration Number: NCT01994369
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Study Start: 2014-05
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EC17 Injection group	EC17	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The number of participants that will have an adverse reaction to the EC17	Day 1- Day 30

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States