Phase 2
N=62
Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00784849 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: 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 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methylene blue (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Primary completion
- Jun 2011
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 | — |
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.
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.