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NCT01994369 · ClinicalTrials.gov registry record · Phase 1
Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01994369: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT01994369 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01994369, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DRUG EC17
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01994369
The ClinicalTrials.gov registry entry for NCT01994369 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EC17 is the first listed.
NCT01994369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01994369 about?
NCT01994369 is a clinical study titled "Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)". 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 surg...
What is the current status of trial NCT01994369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-05. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01994369?
The interventions under investigation include: EC17 (DRUG).
Who is sponsoring clinical trial NCT01994369?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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