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VST-1001 & 99mTc-labeled sulfur colloid for Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Merrick I Ross, MD
Research Sponsored by Vestan, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the secondary outcome is assessed during surgery.
Awards & highlights
Study 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.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the primary outcome is assessed during surgery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the primary outcome is assessed during surgery.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
LYMPH NODE-LEVEL CONCORDANCE of Visually Observed VST-1001 Fluorescence and 99mTc-Labeled Sulfur Colloid Radioactivity, where CONCORDANCE is defined relative to radioactive nodes
Secondary outcome measures
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: VST-1001 & 99mTc-labeled sulfur colloidExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Huntsman Cancer InstituteOTHER
12 Previous Clinical Trials
7,492 Total Patients Enrolled
1 Trials studying Breast Cancer
140 Patients Enrolled for Breast Cancer
Vestan, Inc.Lead Sponsor
M.D. Anderson Cancer CenterOTHER
2,974 Previous Clinical Trials
1,789,327 Total Patients Enrolled
147 Trials studying Breast Cancer
63,139 Patients Enrolled for Breast Cancer
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