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Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients

NCT00507611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2012-09-25

No results posted yet for this study

Summary

The purpose of the present proposed clinical trial will be to assess the utility of SLN mapping and biopsy for predicting the final axillary status after completion of preoperative neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph nodes at initial presentation

Conditions

Interventions

PROCEDURE

Sentinel node mapping

Patients will undergo preoperative lymphoscintigraphy in the nuclear medicine department to access axillary and extra-axillary sites of localization. Intraoperatively, patients will also be injected with approximately 4 to 5 mL of 1% isosulfan blue dye (by intradermal, intraparenchymal, or subareolar route). Patients will undergo intraoperative identification and biopsy of all SLN candidates. A confirmatory axillary lymph node dissection will then be performed on all patients.

Sponsors & Collaborators

  • Stephen Povoski

    lead OTHER

Principal Investigators

  • Stephen P Povoski, MD · Ohio State University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00507611 on ClinicalTrials.gov