Clinical trial NCT00575744: Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation
Official title: Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Sentinel Lymph Node Biopsy
Axillary Node Dissection
Intraoperative Injection
Lumpectomy
Mastectomy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 699
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: To continue gathering data relating to the sentinel lymph node biopsy procedure.
timeFrame: Time of surgery and data analysis
Secondary outcomes:
measure: To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid.
timeFrame: Time of surgery and data analysis
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: V. Suzanne Klimberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.amjsurg.2003.08.014.
citation: 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.
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. doi: 10.1016/s0002-9610(00)00521-3.
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. doi: 10.1016/s0002-9610(00)00500-6.
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. doi: 10.1097/00000658-199906000-00013.
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. doi: 10.1056/NEJM199810013391410. No abstract available.
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. doi: 10.1056/NEJM199810013391401.
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 845-8. doi: 10.1097/01.sla.0000128304.13522.00.
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.
citation: 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.