Status:
COMPLETED
Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer
Lead Sponsor:
Kettering Health Network
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Single center, blinded, randomized, parallel-group, comparative study of Lymphoseek and 99mTc-SC in the preoperative and intraoperative detection of lymph nodes in subjects with known breast cancer. A...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 19 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02287675
Start Date
January 19 2015
End Date
August 31 2017
Last Update
July 28 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kettering Medical Center
Kettering, Ohio, United States, 45429