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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00360152

Enrollment

100

Registered

2006-08-03

Start date

2006-08-31

Completion date

2013-04-30

Last updated

2013-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast Cancer, Axilla, Ultrasound, FNA, Molecular Analysis

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.

Interventions

PROCEDUREFine needle aspiration biopsy (FNAB)

PROCEDURESentinel Lymph Node Biopsy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026