Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

August 3, 2021 updated by: Chongwei Chi, Ph.D, Chinese Academy of Sciences

To Evaluate the Safety and Efficacy of Near-infarred Fluorescence Molecular Imaging in the Prospective, Multi-center and Self-controlled Clinical Trial of Sentinel Lymph Node Biopsy in Breast Cancer Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial was a prospective, multicenter, and self controlled clinical trial. The subjects who were in line with this scheme were detected by fluorimetry and staining, and the primary effectiveness evaluation index, secondary effectiveness evaluation index and safety evaluation index were established during the operation. Record evaluation. At present, in the clinic for sentinel lymph node biopsy of breast cancer, routine medical treatment is a blue staining method. A large number of clinical data show that the number of blue staining methods was 1-2.4, and the number of fluorescence detection is 2-3.7. Therefore, choosing a self controlled clinical trial can increase the number of sentinel lymph node detection.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100190
        • Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self control

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
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.
Other Names:
  • MB
Drug: Indocyanine Green
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
Other Names:
  • ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sentinel lymph node detection number
Time Frame: 1 year
Participants will be followed for the duration of hospital stay, an expected average of 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Sciences

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 19, 2020

Study Registration Dates

First Submitted

June 8, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-DPM-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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