NCT02084784

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

March 8, 2014

Last Update Submit

June 5, 2018

Conditions

Sentinel Lymph NodeBreast Cancer

Keywords

Near-infrared fluorescenceImage guided surgeryBreast cancer;Sentinel lymph node biopsyIndocyanine greenMethylene blue

Outcome Measures

Primary Outcomes (1)

  • Sentinel lymph node detection rate

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

    1 year

Study Arms (1)

Indocyanine green & methylene blue,

EXPERIMENTAL

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

Drug: Indocyanine greenDrug: methylene blue

Interventions

Indocyanine greenDRUG

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

Also known as: ICG
Indocyanine green & methylene blue,
methylene blueDRUG

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

Also known as: MB
Indocyanine green & methylene blue,

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Beijing, Beijing Municipality, 100190, China

Location

Related Publications (3)

  • 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.

    PMID: 24358319RESULT

  • 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.

    PMID: 29290809DERIVED

  • 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.

    PMID: 27497181DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine GreenMethylene Blue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-Ring

Study Officials

  • Chongwei Chi, doctor

    Chinese Academy of Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Study Record Dates

First Submitted

March 8, 2014

First Posted

March 12, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 7, 2018

Record last verified: 2018-06

Locations

CN(1)