Back to resultsSecond Echelon Node Study With Methylene Blue
Primary Purpose
Breast Cancer, Melanoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylene blue dye injection of sentinel lymph node
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer focused on measuring breast cancer, melanoma, sentinel lymph node biopsy, lymphadenectomy
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methylene Blue
Arm Description
1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node
Outcomes
Primary Outcome Measures
The number of subjects in whom a secondary echelon lymph node is identified
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01823172
Brief Title
Second Echelon Node Study With Methylene Blue
Official Title
Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Melanoma
Keywords
breast cancer, melanoma, sentinel lymph node biopsy, lymphadenectomy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylene Blue
Arm Type
Experimental
Arm Description
1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node
Intervention Type
Procedure
Intervention Name(s)
Methylene blue dye injection of sentinel lymph node
Intervention Description
Single arm study. Methylene blue will be injected into the 1st SLN and traced via the efferent lymphatic to the 2nd echelon lymph node.
Primary Outcome Measure Information:
Title
The number of subjects in whom a secondary echelon lymph node is identified
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Jakub, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share data
Learn more about this trial
Second Echelon Node Study With Methylene Blue
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