Second Echelon Node Study With Methylene Blue

Breast Cancer Clinical Trial

Official title:

Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823172
• Other study ID #: 12-009929
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: March 21, 2018
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators plan to study the ability to identify the lymph nodes beyond the sentinel lymph node that may harbor cancer using methylene blue dye.

Description:

After lymphatic mapping of the SLN with Tc-99 sulfur colloid only, the second-echelon lymphatic mapping was then performed with methylene blue dye by injecting the SLN with 0.05-0.10 cc non dilute methylene blue and tracing via the efferent lymphatic channel to the second echelon lymph node (Figure 1). For our initial patients a 27 gauge needle and 3cc syringe was utilized but this was modified over the study to a 30 gauge needle and 1cc syringe. The blue efferent lymphatic was traced with minimal spreading of the surrounding tissue to visualize its drainage into the next lymph node(s). A second echelon lymph node was considered any blue lymph node or any lymph node with blue dye leading directly into it. The number of second echelon lymph nodes was recorded. The second-echelon lymph node(s) was not removed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed primary cutaneous melanoma located on the extremity or trunk

• Patients with clinically stage I-II melanoma

• Histologically confirmed invasive ductal or lobular carcinoma

• Patient undergoing surgical treatment of breast primary and sentinel lymph node biopsy- clinically node negative

Exclusion Criteria:

• Melanoma located on the head or neck, uveal or mucosal

• Previous surgery or radiation in or near the sentinel lymph node biopsy nodal basin

• Preoperative biopsy proven regional lymph node involvement

• Failure of lymphatic mapping with radioactive colloid

• Women who are pregnant or nursing

• Prior ipsilateral axillary surgery or radiation

• Inflammatory breast cancer

• No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen

• Stage IV breast cancer

Related Conditions & MeSH terms

• Breast Cancer
• Melanoma

Intervention

Procedure:
• Methylene blue dye injection of sentinel lymph node
Single arm study. Methylene blue will be injected into the 1st SLN and traced via the efferent lymphatic to the 2nd echelon lymph node.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects in whom a secondary echelon lymph node is identified		one year