Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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).

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT01994369

Recruitment Status:

Completed

Sponsor:

University of Pennsylvania

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There is 1 Location for this study

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Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT01994369

Recruitment Status:

Completed

Sponsor:


University of Pennsylvania

How clear is this clinincal trial information?

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