Second Echelon Node Study With Methylene Blue

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

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.

It had 1 arm (groups): Methylene Blue (experimental).

The registry classes the interventions as procedure.

More on the Plan

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.

Who Took Part

The registry lists 21 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically confirmed primary cutaneous melanoma located on the extremity or trunk. Histologically confirmed invasive ductal or lobular carcinoma.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-04 with completion listed for 2013-11.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: The number of subjects in whom a secondary echelon lymph node is identified (time frame: one year).

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.