Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

NCT03579979 | Completed DMC

• 1 other identifier: CIP-DPM-02
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a prospective, multicenter, self-controlled clinical study. In order to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph node biopsy with novel near-infarred fluorescence imaging system produced by Beijing digital precision medical technology co., LTD. The fluorescence molecular imaging of indocyanine green (ICG) on imaging detection and the control group, routine medical using methylene blue test .The safety and efficacy of fluorescence and staining in sentinel lymph node biopsy of breast cancer were compared.

Conditions

Sentinel Lymph Node; Breast Cancer

Keywords

Near-infrared fluorescence; Image guided surgery; Sentinel lymph node biopsy; Indocyanine green; Methylene blue

Outcome Measures

Primary Outcomes (1)

• Sentinel lymph node detection number

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

  1 year

Study Arms (1)

Self control

EXPERIMENTAL

During the operation, with the fluorescent molecular imaging instrument, the imaging agent (indocyanine green) is illuminated by the probe distance to the tissue surface 10-30cm, and is excited to produce the near infrared fluorescence of the specific wavelength (the human eye is not visible). The system uses a photoelectric coupler to collect the light of the specific spectrum, and the image is collected by the method of correction. The operation was performed to achieve real-time display of lesions. The injection points were selected subcutaneously around the areola or the periphery of the tumor. 1% methylene blue 0.5ml was injected at each point, with a total of 2-3 points. Within 5 minutes, 2.5mg/ml ICG 0.5ml was injected at each point, with a total of 2-3 points.

Drug: Methylene Blue; Drug: Indocyanine Green

Interventions

Methylene Blue DRUG

Subcutaneous injection of injection point at the periphery of the areola or tumor, injecting 1% methylene blue 0.5ml at each point, a total of 2-3 points.

Also known as: MB

Self control

Indocyanine Green DRUG

Within 5 minutes after MB injection, 2.5mg/ml ICG 0.5ml was injected at each point, a total of 2-3 points. Methylene blue and ICG injection points do not coincide

Also known as: ICG

Self control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the age of 18-75 years, female patients;
• the diagnosis of breast cancer by biopsy;
• participants voluntarily participated in the clinical trial and signed informed consent.

You may not qualify if:

• had received SLNB or axillary surgery;
• breast area radiotherapy or neoadjuvant chemotherapy has been accepted.
• clinical hints of axillary lymph node metastasis;
• discovery of distant metastasis;
• inflammatory breast cancer;
• women in pregnancy;
• people with iodine allergy;
• the serum creatinine was \> 1.5 times as high as the upper limit of the normal value.
• to participate in clinical trials of other devices or drugs within one month;
• the researchers consider it inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Beijing Digital Precesion Medicine Company: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Beijing Friendship Hospital: collaborator
• Tangshan People's Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator

Study Sites (1)

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Beijing, Beijing Municipality, 100190, China

Location

Related Publications (2)

• 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: 27497181 RESULT

• 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: 24358319 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Methylene Blue; Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring

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: Associate Professor

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 9, 2018
• Study Start: August 24, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 19, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

CN (1)