Breast Cancer, Sentinel Lymph Node
Conditions
Keywords
Near-infrared fluorescence, Image guided surgery, Sentinel lymph node biopsy, Indocyanine green, Methylene blue
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.
Interventions
DRUGMethylene 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.
DRUGIndocyanine 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
Sponsors
Beijing Digital Precesion Medicine Company
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Friendship Hospital
Tangshan People's Hospital
The Second Hospital of Hebei Medical University
Chinese Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel lymph node detection number | 1 year | Participants will be followed for the duration of hospital stay, an expected average of 1 year |
Countries
China
Outcome results
None listed