VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer
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
2 other identifiers
interventional
147
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started Jun 2014
Shorter than P25 for phase_1 breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
November 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJuly 27, 2015
July 1, 2015
1.6 years
October 22, 2014
July 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Fluorescence and radioactivity data will be collected during the SLNB surgical procedure.
The primary outcome is assessed during surgery.
Secondary Outcomes (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
The secondary outcome is assessed during surgery.
Study Arms (1)
VST-1001 & 99mTc-labeled sulfur colloid
OTHERVST-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vestan, Inc.lead
- M.D. Anderson Cancer Centercollaborator
- Huntsman Cancer Institutecollaborator
Study Sites (2)
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert HI Andtbacka, MD
Vestan, Inc.
- PRINCIPAL INVESTIGATOR
Merrick I Ross, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2014
First Posted
November 19, 2014
Study Start
June 1, 2014
Primary Completion
January 1, 2016
Study Completion
May 1, 2016
Last Updated
July 27, 2015
Record last verified: 2015-07