Infrared Lymphangiography as a Method of Sentinel Node Identification

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

The initial treatment for most people with melanoma involves wide excision of the skin and sentinel node biopsy.

As with other cancers, the status of the sentinel node provides important prognostic information to the patient and physician.

Sentinel node biopsy was first developed using only a blue dye.

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

The registry classes the interventions as drug.

More on the Plan

Patients with melanoma of the trunk or extremities were prospectively enrolled in this trial.

Patients with head and neck melanoma were excluded from this study based on their pilot experience.

ICG is poorly visualized through muscle, and there seems to be high background uptake in the parotid gland; both of these features limit the utility of ICG and fluorescence imaging.

All subjects had T1b or greater melanoma, and met current National Comprehensive Cancer Network (NCCN) guidelines for sentinel node biopsy.

Who Took Part

89 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: Patients must have histologically or cytologically confirmed melanoma. Age \>18 years. Melanoma is extremely uncommon in children, this disease is not relevant in this age group. Ability to understand and the willingness to sign a written informed consent document.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: patients with melanoma on the head or neck are excluded; history of allergic reactions attributed to compounds of similar chemical or biologic composition to ic-green, sodium iodide or other agents used in the study; pregnant women are excluded from this study.

How the Study Was Run

The set-up was 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 2014-06 with completion listed for 2016-01.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 89 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.