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

July 2, 2013 updated by: Washington University School of Medicine

Minimally Invasive Staging of the Axilla in Breast Cancer: A Pilot Study to Assess the Feasibility of Axillary Ultrasound, Fine Needle Aspiration Biopsy and Molecular Analysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Positive Axillary Ultrasound
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: Sentinel Lymph Node Biopsy
Procedure: Fine needle aspiration biopsy (FNAB)
Active Comparator: Negative Axillary Ultrasound
Negative Axillary Ultrasound -> Sentinel Lymph Node Biopsy/Fine Needle Aspiration Biopsy -> Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and Pathology
Procedure: Sentinel Lymph Node Biopsy
Procedure: Fine needle aspiration biopsy (FNAB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the sensitivity of AUS and real-time RT-PCR/RT-LAMP to predict the pathologic status of the axilla in breast cancer patients
Time Frame: At the time of ultrasound guidance and during definitive surgery for cancer
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
Time Frame: At the time of ultrasound guidance and during definitive surgery for cancer
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
Time Frame: At the time of procedure under general anesthesia
At the time of procedure under general anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Society for Surgical Oncologists
Sysmex America, Inc.

Investigators

  • Principal Investigator: Julie A. Margenthaler, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 2, 2006

First Submitted That Met QC Criteria

August 2, 2006

First Posted (Estimate)

August 3, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2013

Last Update Submitted That Met QC Criteria

July 2, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-0530 / 201109077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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