Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

Not Applicable

Completed

• Conditions: Breast Cancer; Sentinel Lymph Node
• Interventions: Drug: Methylene Blue; Drug: Indocyanine Green

• Registration Number: NCT03579979
• Lead Sponsor: Chinese Academy of Sciences

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.

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 Timeline

• Study Start: 2017-08-24
• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-09
• Primary Completion: 2019-08-30
• Study Completion: 2020-08-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self control	Methylene Blue	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.
Self control	Indocyanine Green	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences; 🇨🇳 Beijing, Beijing, China