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

Breast Cancer Clinical Trial

Official title:

Pilot Trial to Determine the Feasibility of a One Step Sentinel Lymph Node Biopsy Procedure Using Radiolabeled Methylene Blue (IND 70,627)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784849
• Other study ID #: LSU #6169
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2008
• Last updated: May 17, 2012
• Start date: November 2004
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Methylene blue
1 mC1

Locations

Country	Name	City	State
United States	University Medical Center	Lafayette	Louisiana
United States	LSU Interim Hospital	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)		intraoperatively; up to 6 hours	Yes
Secondary	Safety (Allergic Reaction to Blue Dye)	number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension	intraoperatively up to 6 hours	Yes
Secondary	Superficial Skin Necrosis	the number of participants who developed post-operative skin necrosis within 2 weeks of surgery	2 weeks postoperatively	Yes