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

Completed · Phase 1

Conditions studied: Resectable Breast Cancer

In brief

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.

Key facts

Study ID

NCT01994369

Run by

University of Pennsylvania

People needed

10

Starts

2014-05-01

Expected to finish

2014-11-01

Last updated by the study team

2018-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.