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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2014
End Date:May 2016
Contact:Maryse Brulotte, BPharm, DESS
Email:maryse.brulotte@vestanmed.com
Phone:801-983-6448

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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.

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.
We found this trial at
2
sites
Salt Lake City, Utah 84112
Phone: 801-585-0550
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-745-0751
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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