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

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

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.

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

One arm diagnostic.

The registry classes the interventions as drug.

More on the Plan

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.

These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.

Who Took Part

62 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Stage 0,I, II breast cancer. Clinical node status N0, N1. No know allergy to iodine, lymphazurin or methylene blue dyes.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: patient cannot be pregnant or nursing; prisoners will not be eligible; women under the age of 18 will not be eligible.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2004-11 with completion listed for 2011-06.

It ran at 2 sites in United States (2).

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: 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) (time frame: intraoperatively; up to 6 hours).

It also tracked 2 secondary outcomes, for example Safety (Allergic Reaction to Blue Dye) and Superficial Skin Necrosis.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Methylene blue (non-peptide stack partner) in 62 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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