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

July 23, 2015 updated by: Vestan, Inc.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

147

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • The University of Utah Huntsman Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: VST-1001 & 99mTc-labeled sulfur colloid

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.
Drug: VST-1001
Single-dose injection (peritumoral, periareolar, and/or intradermal) of VST-1001 administered pre-SLNB procedure; VST-1001 is used with medical devices (blue-light LED illuminator and blue-light filtering eyewear) for lymphatic mapping and localization of lymph nodes during a SLNB procedure.
Other Names:
  • dilute fluorescein
Drug: 99mTc-labeled sulfur colloid
Single-dose injection (peritumoral, periareolar, intradermal, and/or subdermal) of 99mTc-labeled sulfur colloid administered per standard of care; the radioactivity of the radioactive colloid is detected with a gamma probe per standard of care.
Other Names:
  • radiocolloid
  • radiotracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LYMPH NODE-LEVEL CONCORDANCE of Visually Observed VST-1001 Fluorescence and 99mTc-Labeled Sulfur Colloid Radioactivity, where CONCORDANCE is defined relative to radioactive nodes
Time Frame: The primary outcome is assessed during surgery.
Fluorescence and radioactivity data will be collected during the SLNB surgical procedure.
The primary outcome is assessed during surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LYMPH NODE-LEVEL REVERSE CONCORDANCE of Visually Observed VST-1001 Fluorescence and 99mTc-Labeled Sulfur Colloid Radioactivity, where REVERSE CONCORDANCE is defined relative to fluorescent nodes
Time Frame: The secondary outcome is assessed during surgery.
Fluorescence and radioactivity data will be collected during the SLNB surgical procedure.
The secondary outcome is assessed during surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vestan, Inc.

Collaborators

M.D. Anderson Cancer Center
Huntsman Cancer Institute

Investigators

  • Study Director: Robert HI Andtbacka, MD, Vestan, Inc.
  • Principal Investigator: Merrick I Ross, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VST-1001-02
  • 2013-1021 (Other Identifier: The University of Texas M.D. Anderson Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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