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Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

NCT03579979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-08-04

No results posted yet for this study

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.

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • Beijing Digital Precesion Medicine Company

    collaborator UNKNOWN

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Beijing Friendship Hospital

    collaborator OTHER

  • Tangshan People's Hospital

    collaborator OTHER

  • The Second Hospital of Hebei Medical University

    collaborator OTHER

  • Chinese Academy of Sciences

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2019-08-30
Completion
2020-08-19

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579979 on ClinicalTrials.gov