Phase 4
N=40
Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02287675 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Injection Site Clearance for Lymphoseek and 99mTc-Sulfur Colloid (SC). — 1.78; 0.045 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lymphoseek (Drug); Sulfur Colloid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kettering Health Network
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Injection Site Clearance for Lymphoseek and 99mTc-Sulfur Colloid (SC). |
1.78; 0.045 | — |
| PRIMARY Sentinel Lymph Node Uptake Rate |
59.28; 86.46 | — |
| SECONDARY Number of Intraoperatively Detected Sentinel Lymph Nodes (SLNs) Identified |
9; 22 | — |
| SECONDARY Ratio of Intraoperative Gamma Counts |
0.1093; 0.2621 | — |
| SECONDARY Patient Pain Tolerance |
0.5278; 1.5682 | — |
| SECONDARY Pathologic Assessment of the Excised Lymph Node(s) |
2; 0; 7; 22 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02287675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.