Trial record 9 of 13 for:    klimberg and phase II

Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00575744
First received: December 14, 2007
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.


Condition Intervention Phase
Breast Cancer
Procedure: Sentinel Node Biopsy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • To continue gathering data relating to the sentinel lymph node biopsy procedure. [ Time Frame: Time of surgery and data analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid. [ Time Frame: Time of surgery and data analysis ] [ Designated as safety issue: No ]

Enrollment: 699
Study Start Date: December 1998
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1 Procedure: Sentinel Node Biopsy
Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive.
Other Names:
  • Sentinel Node Biopsy
  • Axillary Node Dissection
  • Technitium Sulfur Colloid
  • Lymphazurin Blue Dye

Detailed Description:

Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer requiring lymph node evaluation
  • Clinically negative lymph nodes in the axilla
  • Willing participation following an informed consent process

Exclusion Criteria:

  • Patients with clinically positive lymph nodes
  • Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis)
  • Previous axillary lymphadenectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575744

Locations
United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: V. Suzanne Klimberg, MD University of Arkansas
  More Information

Publications:

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00575744     History of Changes
Other Study ID Numbers: UAMS 04959
Study First Received: December 14, 2007
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Sentinel Lymph Node Biopsy
Axillary Node Dissection
Intraoperative Injection
Lumpectomy
Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014