Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/5/2018 |
| Start Date: | May 2014 |
| End Date: | November 2014 |
A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Surgery Presenting Breast Cancer
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.
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.
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).
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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