Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579979
• Other study ID #: CIP-DPM-02
• Status: Completed
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: August 19, 2020

Study information

• Verified date: August 2021
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 19, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Key Laboratory of Molecular Imaging, Chinese Academy of Sciences	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	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

Country where clinical trial is conducted

China, 

References & Publications (2)

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.po — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentinel lymph node detection number	Participants will be followed for the duration of hospital stay, an expected average of 1 year	1 year