Breast Cancer Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 147 |
Est. completion date | May 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas M.D. Anderson Cancer Center | Houston | Texas |
United States | The University of Utah Huntsman Cancer Institute | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Vestan, Inc. | Huntsman Cancer Institute, M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | 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 | Fluorescence and radioactivity data will be collected during the SLNB surgical procedure. | The secondary outcome is assessed during surgery. | No |
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