Resectable Breast Cancer Clinical Trial
Official title:
A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Surgery Presenting Breast Cancer
| Verified date | June 2018 |
| Source | University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | The number of participants that will have an adverse reaction to the EC17 | Day 1- Day 30 |