Phase 2
Completed N=62
Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)
Source: ClinicalTrials.gov NCT00784849 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) — 58; 55; 55; 0 participants
Summary
The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) |
58; 55; 55; 0 | — |
| SECONDARY Safety (Allergic Reaction to Blue Dye) |
— | — |
| SECONDARY Superficial Skin Necrosis |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Stage 0,I, II breast cancer
- Clinical node status N0, N1
- No know allergy to iodine, lymphazurin or methylene blue dyes
Exclusion Criteria
- Patient cannot be pregnant or nursing
- Prisoners will not be eligible
- Women under the age of 18 will not be eligible
- Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes
Data sourced from ClinicalTrials.gov (NCT00784849). 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. Informational only — not medical advice.