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Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

NCT ID: NCT00575744

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

699 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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Sentinel Lymph Node Biopsy Axillary Node Dissection Intraoperative Injection Lumpectomy Mastectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type NO_INTERVENTION

Sentinel Node Biopsy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Axillary Node Dissection Technitium Sulfur Colloid Lymphazurin Blue Dye

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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V. Suzanne Klimberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14672787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11523106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11182393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11182390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10363900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9753717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9753708 (View on PubMed)

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.

Reference Type RESULT
PMID: 15166963 (View on PubMed)

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.

Reference Type RESULT
PMID: 18777194 (View on PubMed)

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.

Reference Type RESULT
PMID: 21918427 (View on PubMed)

Other Identifiers

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UAMS 04959

Identifier Type: -

Identifier Source: org_study_id