Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

NCT ID: NCT03579979

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-24
• Study Completion Date: 2020-08-19

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.

Conditions

Sentinel Lymph Node; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Methylene Blue

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

MB; ICG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Digital Precesion Medicine Company

UNKNOWN

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

Tangshan People's Hospital

OTHER

Sponsor Role: collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chongwei Chi, Ph.D

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Beijing, Beijing Municipality, China

Countries

China

References

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 different types of hospitals. Transl Res. 2016 Dec;178:74-80. doi: 10.1016/j.trsl.2016.07.010. Epub 2016 Jul 18.

Reference Type: RESULT

PMID: 27497181 (View on PubMed)

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.pone.0083927. eCollection 2013.

Reference Type: RESULT

PMID: 24358319 (View on PubMed)

Other Identifiers

CIP-DPM-02

Identifier Type: -

Identifier Source: org_study_id