Clinical trial NCT02294565: VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Sentinel Lymph Node Biopsy
Breast Cancer
Lymphatic Mapping
Lead sponsor: Vestan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
name: Huntsman Cancer Institute
First posted: 2014-11-19
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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.

Primary outcomes:
measure: LYMPH NODE-LEVEL CONCORDANCE of Visually Observed VST-1001 Fluorescence and 99mTc-Labeled Sulfur Colloid Radioactivity, where CONCORDANCE is defined relative to radioactive nodes
timeFrame: The primary outcome is assessed during surgery.
Secondary outcomes:
measure: 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
timeFrame: The secondary outcome is assessed during surgery.
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Vestan, Inc.
name: Robert HI Andtbacka, MD
role: STUDY_DIRECTOR
affiliation: M.D. Anderson Cancer Center
name: Merrick I Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: