Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer

Completed · Phase 4

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT02287675

Run by

Kettering Health Network

People needed

40

Starts

2015-01-19

Expected to finish

2017-08-31

Last updated by the study team

2020-07-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Kettering Medical Center — Kettering, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.