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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

Thank you

Trial Information

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


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 ciopsied by FNA biopsy at minimal risk to the patient

- Patient must be willing to give informed consent

- Patient with no history of malignancy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Julie A. Margenthaler, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

06-0530 / 201109077

NCT ID:

NCT00360152

Start Date:

August 2006

Completion Date:

November 2013

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Axilla
  • Ultrasound
  • FNA
  • Molecular Analysis
  • Breast Neoplasms
  • Neoplasms

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110