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

Status: Active

Description

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.

Eligibility 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.

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

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 Phase & Type

Trial Phase

Phase I/II

Trial Type

Not provided by clinicaltrials.gov

Lead Organization

Lead Organization
Vestan, Inc.

Trial IDs

Primary ID VST-1001-02
Secondary IDs NCI-2014-02431, 2013-1021
Clinicaltrials.gov ID NCT02294565