Breast CancerNCT01823172
Second Echelon Node Study With Methylene Blue
A study testing Methylene blue dye injection of sentinel lymph node in people with Breast Cancer and Melanoma, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Melanoma
- What is being tested?
- Methylene blue dye injection of sentinel lymph node
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Inflammatory breast cancer
- No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen
- Stage IV breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue
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.
Read the 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.
- Conditions
- Breast Cancer, Melanoma
- Being tested
- Methylene blue dye injection of sentinel lymph node
- Keywords
- breast cancer, melanoma, sentinel lymph node biopsy, lymphadenectomy
- Medical subject headings
- Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blue dye injection of sentinel lymph nodeProcedure or surgery
Single arm study. Methylene blue will be injected into the 1st SLN and traced via the efferent lymphatic to the 2nd echelon lymph node.
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue | Experimental | 1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node Receives: Procedure: Methylene blue dye injection of sentinel lymph node |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects in whom a secondary echelon lymph node is identified
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W. Jakub, Mayo Clinic
- Investigators
- James Jakub, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823172
- Sponsor's protocol ID
- 12-009929
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2013
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue
- ClinicalTrials.gov ID
- NCT01823172
- Acronym / sponsor ID
- 12-009929
- Conditions
- Breast Cancer, Melanoma
- Keywords
- breast cancer, melanoma, sentinel lymph node biopsy, lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue | Experimental | Procedure: Methylene blue dye injection of sentinel lymph node1% Methylene Blue - 1 ml. Methylene blue dye injection of sentinel lymph node |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene blue dye injection of sentinel lymph nodeSingle arm study. Methylene blue will be injected into the 1st SLN and traced via the efferent lymphatic to the 2nd echelon lymph node. | Procedure or surgery | Methylene Blue |
Primary outcome
The number of subjects in whom a secondary echelon lymph node is identified
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Individual participant dataSharing planned: No. no plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Jakub, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene blue dye injection of sentinel lymph node in people with Breast Cancer and Melanoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects in whom a secondary echelon lymph node is identified (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018; AzTrials last refreshed its copy on 26 Oct 2026.