Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02294565
Recruitment Status : Unknown
Verified July 2015 by Vestan, Inc..
Recruitment status was:  Recruiting
First Posted : November 19, 2014
Last Update Posted : July 27, 2015
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Huntsman Cancer Institute
Information provided by (Responsible Party):
Vestan, Inc.

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: VST-1001 Drug: 99mTc-labeled sulfur colloid Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : June 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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 Name: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294565


Contacts
Layout table for location contacts
Contact: Maryse Brulotte, BPharm, DESS 801-983-6448 maryse.brulotte@vestanmed.com

Locations
Layout table for location information
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Dianna L Riall, RN    713-745-0751    DLRiall@mdanderson.org   
United States, Utah
The University of Utah Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Brady Gamble    801-585-0550    brady.gamble@hci.utah.edu   
Sponsors and Collaborators
Vestan, Inc.
M.D. Anderson Cancer Center
Huntsman Cancer Institute
Investigators
Layout table for investigator information
Study Director: Robert HI Andtbacka, MD Vestan, Inc.
Principal Investigator: Merrick I Ross, MD M.D. Anderson Cancer Center

Layout table for additonal information
Responsible Party: Vestan, Inc.
ClinicalTrials.gov Identifier: NCT02294565     History of Changes
Other Study ID Numbers: VST-1001-02
2013-1021 ( Other Identifier: The University of Texas M.D. Anderson Cancer Center )
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Keywords provided by Vestan, Inc.:
Sentinel Lymph Node Biopsy
Breast Cancer
Lymphatic Mapping
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases