Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

Plain-language guide to NCT02084784: not phased interventional trial of Methylene blue (non-peptide stack partner), 98 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02084784
Phase: not phased
Status: completed
Start: 2014-01
Completion (planned or actual): 2015-09
Participants: 98 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Sentinel Lymph Node; Breast Cancer
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Methylene blue (non-peptide stack partner).

It had 1 arm (groups): Indocyanine green & methylene blue, (experimental).

The registry classes the interventions as drug.

More on the Plan

Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups.

In this paper, the investigators introduce a novel surgical navigation system to detect SLN with ICG.

This system contains two charge-coupled devices (CCD) to simultaneously capture real-time color and fluorescent video images through two different bands.

During surgery, surgeons only need to follow the fluorescence display.

Who Took Part

98 actual participants took part.

It was open to women only.

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

Examples of who could join: Tumor diameter ≤ 3cm;. No clinical examination of suspicious axillary lymph node-positive;. Preoperative clinical or radiologic evidence without distant metastases (M0);. Signed informed consent.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: sentinel lymph node biopsy history had received surgery or axillary area;; clinical axillary lymph node metastasis have been found;; mammary area had received neoadjuvant chemotherapy or radiotherapy;.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

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

It started in 2014-01 with completion listed for 2015-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Sentinel lymph node detection rate (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 98 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.