Clinical trial · Interventional
Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research
Study of Surgical Navigation System in Detection of Sentinel Lymph Node of Early Breast Cancer Patients
NCT02084784CI-TRIAL-00033235completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
| methylene blue | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Indocyanine green & methylene blue,
- description
- Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1% Indocyanine green with 1ml of 0.5%
- interventionNames
- Drug: Indocyanine green
- Drug: methylene blue
Primary outcomes (1)
- measure
- Sentinel lymph node detection rate
- timeFrame
- 1 year
- description
- Participants will be followed for the duration of hospital stay, an expected average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion criteria: (Before the test, all the subjects required for meeting the entry requirements before they join the group) * female patients; * The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer; * tumor diameter ≤ 3cm; * No clinical examination of suspicious axillary lymph node-positive; * diagnosed clinical conditions can be directly surgery as I, II breast cancer patients; * preoperative clinical or radiologic evidence without distant metastases (M0); * signed informed consent. Exclusion criteria: (Before the test, the subjects under any one of items to meet the requirements can not be enrolled) * Sentinel lymph node biopsy history had received surgery or axillary area; * multi-center breast cancer or multiple lesions; * clinical axillary lymph node metastasis have been found; * mammary area had received neoadjuvant chemotherapy or radiotherapy; * inflammatory breast cancer; * pregnancy; * no personal freedom and independent civil capacity. Exclusion criteria: (trials, subjects necessary to meet the requirements of any one item, exit the clinical trial research.) * severe allergic reaction occurs; * persistent allergic reaction; * subjects were required to withdraw from a clinical trial; * researchers consider it not appropriate to continue to participate in the clinical trial investigator.
References
Publications (3)
- RESULTChi 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. PMID 24358319
- DERIVEDHe K, Zhou J, Yang F, Chi C, Li H, Mao Y, Hui B, Wang K, Tian J, Wang J. Near-infrared Intraoperative Imaging of Thoracic Sympathetic Nerves: From Preclinical Study to Clinical Trial. Theranostics. 2018 Jan 1;8(2):304-313. doi: 10.7150/thno.22369. eCollection 2018. PMID 29290809
- DERIVEDHe 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. PMID 27497181