Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.

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Detailed Description

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This study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). On the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. The injection will be in the location around the breast tumor. The surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a Geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

One arm diagnostic

Group Type EXPERIMENTAL

Methylene blue

Intervention Type DRUG

1 mC1

Interventions

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Methylene blue

1 mC1

Intervention Type DRUG

Other Intervention Names

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SNL biopsy breast cancer biopsy

Eligibility Criteria

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Inclusion Criteria

* Stage 0,I, II breast cancer
* Clinical node status N0, N1
* No know allergy to iodine, lymphazurin or methylene blue dyes

Exclusion Criteria

* Patient cannot be pregnant or nursing
* Prisoners will not be eligible
* Women under the age of 18 will not be eligible
* Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes