Clinical trial NCT03579979: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sentinel Lymph Node
Breast Cancer
Keywords: Near-infrared fluorescence
Image guided surgery
Sentinel lymph node biopsy
Indocyanine green
Methylene blue
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Digital Precesion Medicine Company
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Beijing Friendship Hospital
name: Tangshan People's Hospital
name: The Second Hospital of Hebei Medical University
First posted: 2018-07-09
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sentinel lymph node detection number
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
state: Beijing
Study officials:
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.
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.