Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG
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|ClinicalTrials.gov Identifier: NCT03579979|
Recruitment Status : Enrolling by invitation
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sentinel Lymph Node Breast Cancer||Drug: Methylene Blue Drug: Indocyanine Green||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 31, 2018|
|Estimated Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: 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.
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.
Other Name: MB
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
Other Name: ICG
- Sentinel lymph node detection number [ Time Frame: 1 year ]Participants will be followed for the duration of hospital stay, an expected average of 1 year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579979
|Key Laboratory of Molecular Imaging, Chinese Academy of Sciences|
|Beijing, Beijing, China, 100190|