Status:
UNKNOWN
VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer
Lead Sponsor:
Vestan, Inc.
Collaborating Sponsors:
M.D. Anderson Cancer Center
Huntsman Cancer Institute
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 dur...
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2016
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT02294565
Start Date
June 1 2014
End Date
May 1 2016
Last Update
July 27 2015
Active Locations (2)
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1
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
2
The University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112