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

NCT ID: NCT02294565

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-05-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

VST-1001

Intervention Type: DRUG

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.

99mTc-labeled sulfur colloid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

dilute fluorescein; radiocolloid; radiotracer

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Huntsman Cancer Institute

OTHER

Sponsor Role: collaborator

Vestan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert HI Andtbacka, MD

Role: STUDY_DIRECTOR

Vestan, Inc.

Merrick I Ross, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

The University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maryse Brulotte, BPharm, DESS

Role: CONTACT

maryse.brulotte@vestanmed.com

801-983-6448

Facility Contacts

Dianna L Riall, RN

Role: primary

DLRiall@mdanderson.org

713-745-0751

Brady Gamble

Role: primary

brady.gamble@hci.utah.edu

801-585-0550

Other Identifiers

2013-1021

Identifier Type: OTHER

Identifier Source: secondary_id

VST-1001-02

Identifier Type: -

Identifier Source: org_study_id