Breast Cancer
Conditions
Keywords
Sentinel Lymph Node Biopsy, Breast Cancer, Lymphatic Mapping
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.
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.
Interventions
DRUGVST-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.
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.
Sponsors
M.D. Anderson Cancer Center
Huntsman Cancer Institute
Vestan, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LYMPH NODE-LEVEL CONCORDANCE of Visually Observed VST-1001 Fluorescence and 99mTc-Labeled Sulfur Colloid Radioactivity, where CONCORDANCE is defined relative to radioactive nodes | The primary outcome is assessed during surgery. | Fluorescence and radioactivity data will be collected during the SLNB surgical procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Fluorescence and radioactivity data will be collected during the SLNB surgical procedure. |
Countries
United States
Contacts
Primary ContactMaryse Brulotte, BPharm, DESS
Outcome results
None listed