Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients

What Was Tested

This registered phase 4 trial tested Methylene blue (non-peptide stack partner).

It had two arms (groups): methylene blue intradermal injection (experimental) and methylene blue subcutaneous injection (active comparator).

The registry classes the interventions as device.

More on the Plan

After fully informing and consent, patients recruited would be randomized 1:1 to intradermal injection group and subcutaneous injection group.

Investigators aimed to find out the difference in sentinel lymph nodes detected rate, blue lymphatic detected rate and complication incidence between the two groups.

Who Took Part

Enrollment: 352 planned participants were the target.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: Who sign the informed consent form. Pathological diagnosed, without distant metastasis, early stage invasive breast cancer patients. Did not undergo neoadjuvant chemotherapy, endocrinotherapy or targeted therapy previously. Without breast and axillary surgery history. Ejection fraction score in normal range accord to cardiac doppler.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: any history of malignant tumor within five years; diagnosis of multi-center, multi-focal or bilateral breast cancer; history of breast tumor incision biopsy or vacuum-assisted biopsy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2015-05 with completion listed for 2017-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): detective rate of sentinel lymph node (time frame: through study completion, an average of 1.5 year).

It also tracked 2 secondary outcomes, for example detective rate of blue lymphatic and incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Methylene blue (non-peptide stack partner) in 352 people.

Its status is unknown; 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.