Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

Breast Cancer Clinical Trial

Official title:

Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575744
• Other study ID #: UAMS 04959
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2007
• Last updated: October 26, 2016
• Start date: December 1998
• Est. completion date: October 2011

Study information

• Verified date: October 2016
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 699
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

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.

Locations

Country	Name	City	State
United States	University of Arkansas For Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (10)

Johnson CB, Boneti C, Korourian S, Adkins L, Klimberg VS. Intraoperative injection of subareolar or dermal radioisotope results in predictable identification of sentinel lymph nodes in breast cancer. Ann Surg. 2011 Oct;254(4):612-8. doi: 10.1097/SLA.0b013 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Thompson M, Korourian S, Henry-Tillman R, Adkins L, Mumford S, Smith M, Klimberg VS. Intraoperative radioisotope injection for sentinel lymph node biopsy. Ann Surg Oncol. 2008 Nov;15(11):3216-21. doi: 10.1245/s10434-008-0010-3. Epub 2008 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To continue gathering data relating to the sentinel lymph node biopsy procedure.		Time of surgery and data analysis	No
Secondary	To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid.		Time of surgery and data analysis	No