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Sentinel Lymph NodeNCT02084784

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

A study testing Indocyanine green and methylene blue in people with Sentinel Lymph Node and Breast Cancer, run by Chinese Academy of Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Sentinel Lymph Node, Breast Cancer
What is being tested?
Indocyanine green and methylene blue
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteChina
Study dates
Jan 2014to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Inclusion criteria: (Before the test, all the subjects required for meeting the entry requirements before they join the group)

  • female patients;
  • The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer;
  • tumor diameter ≤ 3cm;
  • No clinical examination of suspicious axillary lymph node-positive;
  • diagnosed clinical conditions can be directly surgery as I, II breast cancer patients;
  • preoperative clinical or radiologic evidence without distant metastases (M0);
  • signed informed consent.

Exclusion criteria: (Before the test, the subjects under any one of items to meet the requirements can not be enrolled)

  • Sentinel lymph node biopsy history had received surgery or axillary area;
  • multi-center breast cancer or multiple lesions;
  • clinical axillary lymph node metastasis have been found;
  • mammary area had received neoadjuvant chemotherapy or radiotherapy;
  • inflammatory breast cancer;
  • pregnancy;
  • no personal freedom and independent civil capacity.

Exclusion criteria: (trials, subjects necessary to meet the requirements of any one item, exit the clinical trial research.)

  • severe allergic reaction occurs;
  • persistent allergic reaction;
  • subjects were required to withdraw from a clinical trial;
  • researchers consider it not appropriate to continue to participate in the clinical trial investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

    Beijing, Beijing Municipality, 100190

Other trials in China

About this study

Official title: Study of Surgical Navigation System in Detection of Sentinel Lymph Node of Early Breast Cancer Patients

The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system.

Read the detailed description

Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. 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. In addition, the system saves data automatically during surgery enabling surgeons to find the registration point easily according to image recognition algorithms. The investigators aim to show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.

Being tested
Indocyanine green, methylene blue
Keywords
Near-infrared fluorescence, Image guided surgery, Breast cancer;, Sentinel lymph node biopsy, Indocyanine green, Methylene blue
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine greenDrug

    Also called ICG

    Subcutaneous injection around the areola with 2-4 points Indocyanine green with 1ml of 0.5%

  • methylene blueDrug

    Also called MB

    Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1%

Study groups in NCT02084784
Study groupRoleWhat they receive
Indocyanine green & methylene blue,ExperimentalSubcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1% Indocyanine green with 1ml of 0.5%
Receives: Drug: Indocyanine green; Drug: methylene blue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sentinel lymph node detection rate

    Participants will be followed for the duration of hospital stay, an expected average of 1 year

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02084784
Sponsor's protocol ID
2011CB707700
Other IDs
973
Status last verified
Jun 2018
First submitted
8 Mar 2014
Last updated
7 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Chi C, Ye J, Ding H, He D, Huang W, Zhang GJ, Tian J. Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation. PLoS One. 2013 Dec 16;8(12):e83927. doi: 10.1371/journal.pone.0083927. eCollection 2013.

    PubMed 24358319

  • He K, Zhou J, Yang F, Chi C, Li H, Mao Y, Hui B, Wang K, Tian J, Wang J. Near-infrared Intraoperative Imaging of Thoracic Sympathetic Nerves: From Preclinical Study to Clinical Trial. Theranostics. 2018 Jan 1;8(2):304-313. doi: 10.7150/thno.22369. eCollection 2018.

    PubMed 29290809

  • He K, Chi C, Kou D, Huang W, Wu J, Wang Y, He L, Ye J, Mao Y, Zhang GJ, Wang J, Tian J. Comparison between the indocyanine green fluorescence and blue dye methods for sentinel lymph node biopsy using novel fluorescence image-guided resection equipment in different types of hospitals. Transl Res. 2016 Dec;178:74-80. doi: 10.1016/j.trsl.2016.07.010. Epub 2016 Jul 18.

    PubMed 27497181

Questions about this trial

What is this clinical trial studying?

A study testing Indocyanine green and methylene blue in people with Sentinel Lymph Node and Breast Cancer, run by Chinese Academy of Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sentinel lymph node detection rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02084784, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.

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