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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
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Chongwei Chi, Ph.D, Chinese Academy of Sciences

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.

Condition or disease Intervention/treatment Phase
Sentinel Lymph Node Breast Cancer Drug: Methylene Blue Drug: Indocyanine Green Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
China, Beijing
Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
Beijing, Beijing, China, 100190
Sponsors and Collaborators
Chinese Academy of Sciences
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

Publications of Results:
Responsible Party: Chongwei Chi, Ph.D, Associate Professor, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT03579979     History of Changes
Other Study ID Numbers: CIP-DPM-02
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chongwei Chi, Ph.D, Chinese Academy of Sciences:
Near-infrared fluorescence
Image guided surgery
Sentinel lymph node biopsy
Indocyanine green
Methylene blue

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action