Clinical trial · Interventional
Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer
A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With Breast Cancer
- 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)
RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread. PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isosulfan Blue | Drug | — | UNRESOLVED |
| Lymphangiography | Procedure | — | UNRESOLVED |
| Technetium Tc 99m sulfur colloid | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Injection Methods
- description
- One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)
- interventionNames
- Drug: Isosulfan Blue
- Procedure: Lymphangiography
- Radiation: Technetium Tc 99m sulfur colloid
Primary outcomes (2)
- measure
- Lymphatic drainage patterns as determined by peritumoral and subareolar injections
- timeFrame
- 12 months to collect data
- description
- Evaluate outcome descriptively.
- measure
- Identification rate of sentinel nodes and negative predictive value associated with subareolar injection
- timeFrame
- 12 months to collecte data
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion. 2. Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection. 3. Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry. 4. Patients must sign an informed consent and be registered before the procedure is performed. Exclusion Criteria: 1. A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study. 2. Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry. 3. Patients with known allergy to isosulfan blue dye or any related compounds.
References
Publications (0)
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