Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

Plain-language guide to NCT00314405: not phased non-randomized trial of Methylene blue (non-peptide stack partner), 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00314405
Phase: not phased
Status: completed
Start: 2006-04
Completion (planned or actual): 2007-04
Participants: 100 (estimated)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: Infiltrative Breast Cancer
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision.

Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer.

After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed.

The registry classes the interventions as drug and procedure.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to women only 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 with infiltrative breast cancer (diagnosed pre-operatively by core biopsy). Approval and informed consent.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: locoregional radiotherapy; prevalent axillary lymph node.

How the Study Was Run

The set-up was non-randomized, 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 2006-04 with completion listed for 2007-04.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.

It also tracked 2 secondary outcomes, for example Comparison of the results of SLN serial sectioning, with H&E and IHC staining and Economical evaluation of SLN procedure.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Methylene blue (non-peptide stack partner) in 100 people.

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.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Methylene blue (non-peptide stack partner) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.