Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer

• Status: Completed
• Trial end date: 2017-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

To compare the kinetics and efficacy of two functionally different diagnostic agents, Lymphoseek (CD206 receptor targeted) and 99mTc-Sulfur Colloid (SC) (Sulfur Colloid non-specific mapping agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kettering Health Network
• Treatments: Dextrans; Technetium Tc 99m Pentetate

Criteria

Inclusion Criteria:

• The subject must be female and 18 years of age or older.

• The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer

• The subject must have a diagnosis of primary breast cancer.

• The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.

• The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2

• The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study

Exclusion Criteria:

• The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.

• The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.

• The subject has a positive pregnancy test or is lactating.

• The subject has had prior surgery to the indicated breast or axilla.