Clinical trial · Observational
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.
- 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)
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization. In this study, our hypothesis are as following: 1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. 2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Breast Neoplasm | Benign Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- non-palpable lesion localization rate
- timeFrame
- up to 6month
- description
- non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients
Secondary outcomes (1)
- measure
- lesion of resection size, completeness of resection
- timeFrame
- up to 6month
- description
- actual lesion of width\*height\*length / resection lesion of width\*height\*length
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer. * patients who need breast biopsy as treatment for breast cancer. * Eastern Cooperative Oncology Group Performance status 0 or 1 * consented patients with more than 20 years, less than 70 years Exclusion Criteria: * nonpalpable benign breast lesion ≥ 2cm in patients with breast cancer. * pregnancy * history of severe allergy to ICG(Indocyanine Green) * iode hypersensitiveness
References
Publications (0)
Data not yet available