Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

NCT00575744 | Completed Phase 2

• 1 other identifier: UAMS 04959
• Study Type: interventional
• Target: 699
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Sentinel Lymph Node Biopsy; Axillary Node Dissection; Intraoperative Injection; Lumpectomy; Mastectomy

Outcome Measures

Primary Outcomes (1)

• To continue gathering data relating to the sentinel lymph node biopsy procedure.

  Time of surgery and data analysis

Secondary Outcomes (1)

• 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

Study Arms (1)

1

NO INTERVENTION

Procedure: Sentinel Node Biopsy

Interventions

Sentinel Node Biopsy PROCEDURE

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.

Also known as: Axillary Node Dissection, Technitium Sulfur Colloid, Lymphazurin Blue Dye

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (10)

• 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. doi: 10.1016/j.amjsurg.2003.08.014.

  PMID: 14672787 BACKGROUND

• Rubio IT, Klimberg VS. Techniques of sentinel lymph node biopsy. Semin Surg Oncol. 2001 Apr-May;20(3):214-23. doi: 10.1002/ssu.1036.

  PMID: 11523106 BACKGROUND

• 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. doi: 10.1016/s0002-9610(00)00521-3.

  PMID: 11182393 BACKGROUND

• 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. doi: 10.1016/s0002-9610(00)00500-6.

  PMID: 11182390 BACKGROUND

• 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. doi: 10.1097/00000658-199906000-00013.

  PMID: 10363900 BACKGROUND

• 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. doi: 10.1056/NEJM199810013391410. No abstract available.

  PMID: 9753717 BACKGROUND

• 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. doi: 10.1056/NEJM199810013391401.

  PMID: 9753708 BACKGROUND

• 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. doi: 10.1097/01.sla.0000128304.13522.00.

  PMID: 15166963 RESULT

• 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.

  PMID: 18777194 RESULT

• 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.0b013e31823005bf.

  PMID: 21918427 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• V. Suzanne Klimberg, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: December 1, 1998
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)