Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

• Status: Completed
• Trial end date: 2020-08-19
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Sciences
• Collaborators: Beijing Digital Precesion Medicine Company; Beijing Friendship Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Tangshan People's Hospital; The Second Hospital of Hebei Medical University
• Treatments: Methylene Blue

Criteria

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.