## Protocol Section
### Identification Module
**NCT ID:** NCT03579979

**Brief Title:** Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

**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

#### Organization Study ID Info
**ID:** CIP-DPM-02
#### Organization
**Class:** OTHER_GOV
**Full Name:** Chinese Academy of Sciences
### Status Module
#### Completion Date
**Date:** 2020-08-19

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-08-04

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-08-30

**Type:** ACTUAL

#### Start Date
**Date:** 2017-08-24

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2018-07-09
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-08
**Study First Submit QC Date:** 2018-07-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Beijing Digital Precesion Medicine Company

**Class:** OTHER

**Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences

**Class:** OTHER

**Name:** Beijing Friendship Hospital

**Class:** OTHER

**Name:** Tangshan People's Hospital

**Class:** OTHER

**Name:** The Second Hospital of Hebei Medical University

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Chinese Academy of Sciences

#### Responsible Party

**Investigator Affiliation:** Chinese Academy of Sciences

**Investigator Full Name:** Chongwei Chi, Ph.D

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Sentinel Lymph Node

- Breast Cancer

**Keywords:**

- Near-infrared fluorescence

- Image guided surgery

- Sentinel lymph node biopsy

- Indocyanine green

- Methylene blue

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 130

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Methylene Blue

- Drug: Indocyanine Green

**Label:** Self control

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Self control

**Description:** 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.

**Name:** Methylene Blue

**Other Names:**

- MB

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Self control

**Description:** 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

**Name:** Indocyanine Green

**Other Names:**

- ICG

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Participants will be followed for the duration of hospital stay, an expected average of 1 year

**Measure:** Sentinel lymph node detection number

**Time Frame:** 1 year

### Eligibility Module

**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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

**State:** Beijing

**Zip:** 100190

### References Module

#### References

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

**PMID:** 27497181

**Citation:** 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.

**PMID:** 24358319

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11726

- Name: Methylene Blue

- Relevance: HIGH

- As Found: Hyperactivity Disorder

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008751

- Term: Methylene Blue

### Misc Info Module

- Version Holder: 2024-05-24
