Breast Cancer Clinical Trial
Official title:
A Phase I/II Study of VST-1001 (Dilute Fluorescein) for Lymphatic Mapping and Localization of Lymph Nodes Draining a Primary Tumor Site in Patients With Clinically Node Negative Breast Cancer
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.
The study is a single center prospective, non randomized, single arm, open label, single
dose VST-1001 study for lymphatic mapping and localization of lymph nodes draining a primary
tumor site in patients with clinically node negative breast cancer.
This study evaluates the combined modality technique of investigational VST-1001 with
companion medical devices (replacing the blue dye) and 99mTc-labeled sulfur colloid for
concordance in lymphatic mapping and localization of lymph nodes in patients who are
undergoing a sentinel lymph node biopsy (SLNB) surgical procedure.
This purpose of the Phase I study is to determine a safe and effective recommended dose of
VST-1001 for intraoperative lymphatic mapping and localization of lymph nodes draining a
breast tumor. The purpose of the Phase II study is to further evaluate the Phase I study
recommended dose of VST-1001 and to evaluate its ability to provide intraoperative
visualization of the lymphatic system and lymph nodes draining the primary tumor in patients
diagnosed with breast cancer.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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