Clinical trial · Interventional
Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)
Pilot Trial to Determine the Feasibility of a One Step Sentinel Lymph Node Biopsy Procedure Using Radiolabeled Methylene Blue (IND 70,627)
NCT00784849CI-TRIAL-00007223completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylene blue | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- One arm diagnostic
- interventionNames
- Drug: Methylene blue
Primary outcomes (1)
- measure
- 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)
- timeFrame
- intraoperatively; up to 6 hours
Secondary outcomes (2)
- measure
- Safety (Allergic Reaction to Blue Dye)
- timeFrame
- intraoperatively up to 6 hours
- description
- number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.