drugset / Trial / NCT02294565
VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer
Phase 1/2
Unknown
147 enrolled
Vestan, Inc.
Huntsman Cancer Institute · collabM.D. Anderson Cancer Center · collab
NaSingle-groupOpen-label
Summary
The purpose of this Phase 1 portion of this clinical research study is to find out what dose of dilute fluorescein is needed for a surgeon to best see important lymph nodes that need to be removed during surgery (a standard of care surgery referred to as a Sentinel Lymph Node Biopsy procedure) in patients diagnosed with breast cancer. The purpose of the Phase 2 portion of this clinical research study is to find out if giving dilute fluorescein sodium in combination with a radiotracer (a drug that is radioactive) can help surgeons localize the lymph nodes that need to be removed in patients diagnosed by breast cancer.
Timeline
- Start
- 2014-06
- Primary completion
- 2016-01
- Completion
- 2016-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Technetium Tc-99m Sulfur Colloid | Diagnostic / imaging agent | — | Other |
| Subject | VST-1001 | Diagnostic / imaging agent | — | Other |