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

Vestan

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: 99mTc-labeled sulfur colloid; Drug: VST-1001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02294565

2013-1021 (Other Identifier)

VST-1001-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 147 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

147 participants in 1 patient group

VST-1001 & 99mTc-labeled sulfur colloid

Other group

Description:

VST-1001 (with medical devices) and 99mTc-labeled sulfur colloid are used together during a SLNB procedure in a single subject. Both drugs are evaluated for lymphatic mapping and localization of lymph nodes. The current standard of care for lymphatic mapping and lymph node localization during a SLNB procedure is a combined-modality technique that employs both a radiotracer (99mTc-labeled sulfur colloid is the radiotracer used in this study) and a vital blue dye (a patient receives both drugs). In this study, the vital blue dye is replaced with VST-1001 and companion medical devices. VST-1001 is excited by a medical device (blue-light LED illuminator) to fluoresce; the surgeon is wearing blue-light filtering eyewear to improve visualization of the relevant tissue structures.

Treatment:

Drug: VST-1001

Drug: 99mTc-labeled sulfur colloid