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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02294565

Run by

Vestan, Inc.

People needed

147

Starts

2014-06-01

Expected to finish

2016-05-01

Last updated by the study team

2015-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• The University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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