Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

Sponsor

Chinese Academy of Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03579979

Collaborator

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

130

Enrollment

Location

Arm

35.8

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sentinel Lymph Node Breast Cancer	Drug: Methylene Blue Drug: Indocyanine Green	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 24, 2017

Actual Primary Completion Date :

Aug 30, 2019

Actual Study Completion Date :

Aug 19, 2020

Arms and Interventions

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

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:

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

Outcome Measures

Primary Outcome Measures

Sentinel lymph node detection number [1 year]
Participants will be followed for the duration of hospital stay, an expected average of 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.