Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00575744

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

U.S. FDA Resources

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 ]

Estimated Enrollment:	1000
Study Start Date:	December 1998
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention	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.

Arms

Assigned Interventions

1: No Intervention

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.

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

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

Contacts

Contact: Laura Adkins, MAP, CCRP	501-296-1501 ext 11231	lladkins@uams.edu
Contact: Maureen Smith, RNP	501-296-1505 ext 1115	smithmaureena@uams.edu

Locations

United States, Arkansas
University of Arkansas For Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: V. Suzanne Klimberg, MD

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

V. Suzanne Klimberg, MD

University of Arkansas

More Information

Publications:

Layeeque R, Kepple J, Henry-Tillman RS, Adkins L, Kass R, Colvert M, Gibson R, Mancino A, Korourian S, Klimberg VS. Intraoperative subareolar radioisotope injection for immediate sentinel lymph node biopsy. Ann Surg. 2004 Jun;239(6):841-5; discussion 845-8.

Layeeque R, Henry-Tillman R, Korourian S, Kass R, Klimberg VS. Subareolar sentinel node biopsy for multiple breast cancers. Am J Surg. 2003 Dec;186(6):730-5; discussion 735-6.

Rubio IT, Klimberg VS. Techniques of sentinel lymph node biopsy. Semin Surg Oncol. 2001 Apr-May;20(3):214-23. Review.

Smith LF, Cross MJ, Klimberg VS. Subareolar injection is a better technique for sentinel lymph node biopsy. Am J Surg. 2000 Dec;180(6):434-7; discussion 437-8.

Smith LF, Rubio IT, Henry-Tillman R, Korourian S, Klimberg VS. Intraoperative ultrasound-guided breast biopsy. Am J Surg. 2000 Dec;180(6):419-23.

Klimberg VS, Rubio IT, Henry R, Cowan C, Colvert M, Korourian S. Subareolar versus peritumoral injection for location of the sentinel lymph node. Ann Surg. 1999 Jun;229(6):860-4; discussion 864-5.

McMasters KM, Giuliano AE, Ross MI, Reintgen DS, Hunt KK, Byrd DR, Klimberg VS, Whitworth PW, Tafra LC, Edwards MJ. Sentinel-lymph-node biopsy for breast cancer--not yet the standard of care. N Engl J Med. 1998 Oct 1;339(14):990-5. No abstract available.

Krag D, Weaver D, Ashikaga T, Moffat F, Klimberg VS, Shriver C, Feldman S, Kusminsky R, Gadd M, Kuhn J, Harlow S, Beitsch P. The sentinel node in breast cancer--a multicenter validation study. N Engl J Med. 1998 Oct 1;339(14):941-6.

Responsible Party:	University of Arkansas for Medical Sciences ( V. Suzanne Klimberg, MD )
Study ID Numbers:	UAMS 04959
Study First Received:	December 14, 2007
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00575744 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

Sentinel Lymph Node Biopsy
Axillary Node Dissection
Intraoperative Injection
Lumpectomy
Mastectomy

Study placed in the following topic categories:

Skin Diseases
Anesthetics
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009