Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes

NCT00360152 | Completed Early Phase 1

• 1 other identifier: 06-0530 / 201109077
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sentinel lymph node biopsy (SLNB) has recently emerged as a less invasive alternative to axillary lymph node dissection (ALND) in the treatment of breast cancer. However, SLNB has a number of limitations, and we believe that alternative strategies for staging of the axilla should be explored. The hypothesis of this proposal is that the combination of preoperative high-resolution axillary ultrasound (AUS), fine needle aspiration biopsy (FNAB), and molecular analysis using real-time reverse transcription-polymerase chain reaction (RT-PCR) represents a viable, minimally invasive alternative to SLNB. We propose a prospective cohort study to rigorously assess the diagnostic accuracy of molecular analysis of AUS-FNAB specimens. The primary endpoint of this study is to determine the feasibility of AUS-FNAB and real-time RT-PCR to predict the pathologic status of the axilla in a proof-of-principle study. In the short term, validation of this innovative strategy is likely to reduce the number of sentinel node procedures. In the long term, we believe that AUS-FNAB may ultimately replace SLNB.

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Axilla; Ultrasound; FNA; Molecular Analysis

Outcome Measures

Primary Outcomes (3)

• Determine the sensitivity of AUS and real-time RT-PCR/RT-LAMP to predict the pathologic status of the axilla in breast cancer patients

  At the time of ultrasound guidance and during definitive surgery for cancer

• Determine the feasibility of AUS, FNAB, and RT-PCR/RT-LAMP as an alternative to SLNB for axillary staging of breast cancer patients

  At the time of ultrasound guidance and during definitive surgery for cancer

• Define baseline gene expression levels in lymph nodes by RT-PCR/RT-LAMP in patients with no evidence of malignancy undergoing procedures under general anesthesia

  At the time of procedure under general anesthesia

Study Arms (2)

Positive Axillary Ultrasound

ACTIVE COMPARATOR

Positive Axillary Ultrasound -\> Fine Needle Aspiration Biopsy -\> Cytopathology and Reverse Transcription-Polymerase Chain Reaction (RT-PCR) -\> Positive Cyto=Axillary Lymph Node Dissection, Negative Cyto=Sentinel Lymph Node Biopsy -\> Pathology

Procedure: Fine needle aspiration biopsy (FNAB); Procedure: Sentinel Lymph Node Biopsy

Negative Axillary Ultrasound

ACTIVE COMPARATOR

Negative Axillary Ultrasound -\> Sentinel Lymph Node Biopsy/Fine Needle Aspiration Biopsy -\> Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and Pathology

Procedure: Fine needle aspiration biopsy (FNAB); Procedure: Sentinel Lymph Node Biopsy

Interventions

Fine needle aspiration biopsy (FNAB) PROCEDURE

Negative Axillary Ultrasound; Positive Axillary Ultrasound

Sentinel Lymph Node Biopsy PROCEDURE

Negative Axillary Ultrasound; Positive Axillary Ultrasound

Eligibility Criteria

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

You may qualify if:

• Female patients, aged 18 and over.
• Patients must be newly diagnosed with clinical stage I or II breast cancer and be eligible for breast surgery and core breast biopsy of their proven breast carcinoma.

You may not qualify if:

• Inability to give informed consent
• Contraindications for breast surgery or biopsy
• Patients with no evidence of malignancy scheduled to undergo procedures under general anesthesia must fulfill the following eligibility requirements:
• Female patients, aged 18 and over
• Patient must be scheduled to undergo a procedure under general anesthesia with access to lymph nodes that can be biopsied by FNA biopsy at minimal risk to the patient
• Patient must be willing to give informed consent
• Patient with no history of malignancy

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Society for Surgical Oncologists: collaborator
• Sysmex America, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (20)

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Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Fine-Needle; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques; Lymph Node Excision

Study Officials

• Julie A. Margenthaler, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2006
• First Posted: August 3, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2013
• Last Updated: July 4, 2013

Record last verified: 2013-07

Locations

US (1)