Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer

NCT00450723 | Completed Results DMC

• 3 other identifiers: 20040015SCCC-2003161WIRB-20050911
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (3)

• Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy

  5 years

• Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes

  5 years

• Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes

  5 years

Study Arms (1)

Sentinel Lymph Node Biopsy

EXPERIMENTAL

Drug: Isosulfan blue; Procedure: Axillary Lymph Node Dissection; Procedure: Surgery; Procedure: Sentinel Lymph Node Biopsy; Procedure: Thoracoscopic Surgery; Radiation: Technetium Tc 99m Sulfur Colloid

Interventions

Isosulfan blue DRUG

Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.

Also known as: Lymphazurin

Sentinel Lymph Node Biopsy

Axillary Lymph Node Dissection PROCEDURE

Axillary Lymph Node Dissection

Sentinel Lymph Node Biopsy

Surgery PROCEDURE

The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.

Sentinel Lymph Node Biopsy

Sentinel Lymph Node Biopsy PROCEDURE

Sentinel Lymph Node Biopsy

Sentinel Lymph Node Biopsy

Thoracoscopic Surgery PROCEDURE

Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.

Sentinel Lymph Node Biopsy

Technetium Tc 99m Sulfur Colloid RADIATION

Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots

Sentinel Lymph Node Biopsy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 mediastinum

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Avisar 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

iso-sulfan blue; Surgical Procedures, Operative; Sentinel Lymph Node Biopsy; Thoracoscopy; Technetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Lymph Node Excision; Investigative Techniques; Endoscopy; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Sulfur Compounds; Inorganic Chemicals; Technetium Compounds

Limitations and Caveats

A total of 39 subjects were enrolled however; only 34 of the subjects had identifiable internal mammary sentinel lymph nodes. As a result, the data of 34 subjects were analyzed.

Results Point of Contact

• Title: Eli Avisar MD
• Organization: UM/Sylvester Comprehensive Cancer Center

eavisar@med.miami.edu

305-243-4902

Study Officials

• Eli Avisar, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: May 1, 2004
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 7, 2017
• Results First Posted: April 5, 2013

Record last verified: 2016-12

Locations

US (1)