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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02294565.
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.
Trial PhasePhase I/II
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationVestan, Inc.
