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Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG
Plain-language guide to NCT03579979: not phased interventional trial of Methylene blue (non-peptide stack partner), 130 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03579979
- Phase
- not phased
- Status
- completed
- Start
- 2017-08-24
- Completion (planned or actual)
- 2019-08-30
- Participants
- 130 (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
In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).
This clinical trial is a prospective, multicenter, self-controlled clinical study.
It had 1 arm (groups): Self control (experimental).
The registry classes the interventions as drug.
More on the Plan
This trial was a prospective, multicenter, and self controlled clinical trial.
A large number of clinical data show that the number of blue staining methods was 1-2.4, and the number of fluorescence detection is 2-3.7.
Who Took Part
The registry lists 130 actual participants took part.
It was open to women only aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: The age of 18-75 years, female patients;. Participants voluntarily participated in the clinical trial and signed informed consent.
The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: had received slnb or axillary surgery;; breast area radiotherapy or neoadjuvant chemotherapy has been accepted; clinical hints of axillary lymph node metastasis;.
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 2017-08-24 with completion listed for 2019-08-30.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Sentinel lymph node detection number (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 130 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.
Related Pages
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.