drugset / Trial / NCT03579979
Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG
Completed
130 enrolled
Chinese Academy of Sciences
Beijing Digital Precesion Medicine Company · collabBeijing Friendship Hospital · collabCancer Institute and Hospital, Chinese Academy of Medical Sciences · collabTangshan People's Hospital · collabThe Second Hospital of Hebei Medical University · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-08-24
- Primary completion
- 2019-08-30
- Completion
- 2020-08-19
Publications
- Results He K, Chi C, Kou D, Huang W, Wu J, Wang Y, He L, Ye J, Mao Y, Zhang GJ, Wang J, Tian J. Comparison between the indocyanine green fluorescence and blue dye methods for sentinel lymph node biopsy using novel fluorescence image-guided resection equipment in different types of hospitals. Transl Res. 2016 Dec;178:74-80. doi: 10.1016/j.trsl.2016.07.010. Epub 2016 Jul 18.
- Results Chi C, Ye J, Ding H, He D, Huang W, Zhang GJ, Tian J. Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation. PLoS One. 2013 Dec 16;8(12):e83927. doi: 10.1371/journal.pone.0083927. eCollection 2013.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indocyanine Green | Diagnostic / imaging agent | 0.5 ml | Subcutaneous |
| Subject | Methylene Blue | Diagnostic / imaging agent | 0.5 ml | Subcutaneous |