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Completed

NCT Number: NCT03579979

Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Beijing, Beijing Municipality, 100190, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the age of 18-75 years, female patients;
  • the diagnosis of breast cancer by biopsy;
  • participants voluntarily participated in the clinical trial and signed informed consent.

Exclusion criteria

  • had received SLNB or axillary surgery;
  • breast area radiotherapy or neoadjuvant chemotherapy has been accepted.
  • clinical hints of axillary lymph node metastasis;
  • discovery of distant metastasis;
  • inflammatory breast cancer;
  • women in pregnancy;
  • people with iodine allergy;
  • the serum creatinine was > 1.5 times as high as the upper limit of the normal value.
  • to participate in clinical trials of other devices or drugs within one month;
  • the researchers consider it inappropriate to participate in this clinical trial.

Treatment and study plan

Methylene Blue

Drug

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 names: MB

Indocyanine green

Drug

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 names: ICG

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Beijing Digital Precesion Medicine Company
  • Beijing Friendship Hospital
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Tangshan People's Hospital
  • The Second Hospital of Hebei Medical University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 9, 2018
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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