Overview

VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer

Status:
Unknown status
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vestan, Inc.
Collaborators:
Huntsman Cancer Institute
M.D. Anderson Cancer Center
Criteria
Inclusion Criteria:

- Diagnosis of primary breast cancer.

- Diagnosed with invasive adenocarcinoma, or DCIS for which a SLNB is the recommended
standard of care, or breast cancer with all of the following conditions met:

- FNA results positive for cancer cells

- positive clinical breast examination

- mammography and/or US and/or MRI abnormality(ies) consistent with malignancy.

- N0 and M0 at the time of study entry.

- ECOG 0, 1, or 2

Exclusion Criteria:

- A tumor with direct extension to the chest wall and/or to the skin.

- Diffuse tumors or multiple malignant tumors in the breast.

- Prior breast malignancy of the ipsilateral breast.

- Patient currently receiving or had prior treatment for the currently diagnosed breast
cancer.

- Medical conditions and/or prior surgical procedures that have the potential to
substantially alter the lymphatic drainage pattern from the primary tumor to the lymph
node basin.

- Inability to localize 1 or 2 lymph node drainage basin(s) via lymphatic mapping.