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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT02982148 (opens ClinicalTrials.gov in a new tab)Other idSLNB5010
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
352 participants (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
May 2015
Primary completion
Jan 2017 (estimated)
Completion
Jan 2017 (estimated)
First posted
5 Dec 2016 (estimated)
Last update posted
5 Dec 2016 (estimated)
Conditions
Breast Cancer Female · Early-Stage Breast Cancer · Sentinel Lymph Node

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

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

    NCT02982148

    May 2015 to est. Jan 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is designed to compare the effectiveness of intradermal injection and subcutaneous injection with methylene blue for early-stage breast cancer patients who need sentinel lymph node biopsy.

Interventions

  • methylene blue intradermal injectionDevice
  • methylene blue subcutaneous injectionDevice

Arms2

  • Experimental

    methylene blue intradermal injection

    For patients randomized to intradermal injection before surgery began, 0.5ml 0.4% methylene blue(1ml methylene blue mixed up with 1.5ml saline) would be injected sub-areola (12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock) intradermally, 0.1ml respectively, or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes.

  • Active comparator

    methylene blue subcutaneous injection

    For patients randomized to subcutaneous injection before surgery began, 0.5ml 100% methylene blue would be injected sub-areola subcutaneously(12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock), 0.1ml respectively or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. detective rate of sentinel lymph node

    Time frame · through study completion, an average of 1.5 year

    Registry description

    Right after each of the sentinel lymph node biopsy, the investigators would collect data of whether it was successful or not and the amount of sentinel lymph nodes that shown out by the certain intervention.

Secondary outcomes(2)

  1. detective rate of blue lymphatic

    Time frame · through study completion, an average of 1.5 year

    Registry description

    The researcher would record if the surgeons could see blue lymphatic during the procedure of locating sentinel lymph node in use of the certain intervention.

  2. incidence of adverse events

    Time frame · 1 month after surgery

    Registry description

    One month after surgery, researchers would record if any adverse events appeared by phone call follow-up.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2006

Can methylene blue only be used in sentinel lymph node biopsy for breast cancer?

Golshan et al. 2006The breast journalcited by 48

PMID 16958960DOI 10.1111/j.1075-122x.2006.00299.xPUB-16958960

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * Eastern Cooperative Oncology Group score ≤0-2 * axillary lymph node clinical negative Exclusion Criteria: * pregnancy * 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 * methylene blue allergic * appear with severe systematic disease or disfunction of any organ

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