Clinical trial · Interventional
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
Thoracoscopic Internal Mammary Sentinel Node Biopsy
NCT00450723CI-TRIAL-00025839completedN/AResults 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)
RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment. PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary Lymph Node Dissection | Procedure | — | UNRESOLVED |
| Isosulfan blue | Drug | — | UNRESOLVED |
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
| Technetium Tc 99m Sulfur Colloid | Radiation | — | UNRESOLVED |
| Thoracoscopic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel Lymph Node Biopsy
- interventionNames
- Drug: Isosulfan blue
- Procedure: Axillary Lymph Node Dissection
- Procedure: Surgery
- Procedure: Sentinel Lymph Node Biopsy
- Procedure: Thoracoscopic Surgery
- Radiation: Technetium Tc 99m Sulfur Colloid
Primary outcomes (3)
- measure
- Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
- timeFrame
- 5 years
- measure
- Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
- timeFrame
- 5 years
- measure
- Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage I or II disease (T1-T2, N0, M0/MX disease)
* No chest wall invasion by tumor (T3 disease)
* Medially or centrally located lesion
* No multicentric disease
* Multifocal disease allowed
* No clinically positive axillary nodes
* No enlarged internal mammary nodes by CT scan
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* American Society of Anesthesiologists (ASA) physical status classification 1-2
* Not pregnant or nursing
* Negative pregnancy test
* No other concurrent known, invasive malignancy
* No known chronic pulmonary disease
* No known allergy to methylene blue or isosulfan blue
PRIOR CONCURRENT THERAPY:
* No prior thoracic or cardiac surgery
* No prior ipsilateral chest tube placement
* Contralateral chest tube placement allowed
* No prior neoadjuvant chemotherapy
* No prior radiotherapy to the mediastinumReferences
Publications (1)
- RESULTAvisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23. PMID 18723148